Intuitive Surgical, Inc.
Sunnyvale, CA, US
INTUITIVE SURGICAL, INC. appears in FDA device records in Sunnyvale, CA. FDA records list 196 510(k) clearances between and , no PMA records and 9 registered establishments. As of , FDA records show 277 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 196FDA records hold 196 510(k) clearances for Intuitive Surgical, Inc. between 1997 and 2026. The busiest year on record is 2025, with 21. The most recent is 2026, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 4 |
| 2002 | 4 |
| 2004 | 4 |
| 2005 | 5 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 7 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 8 |
| 2012 | 4 |
| 2013 | 5 |
| 2014 | 13 |
| 2015 | 6 |
| 2016 | 9 |
| 2017 | 16 |
| 2018 | 13 |
| 2019 | 10 |
| 2020 | 9 |
| 2021 | 9 |
| 2022 | 7 |
| 2023 | 7 |
| 2024 | 15 |
| 2025 | 21 |
| 2026 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | FDS | Substantially Equivalent | |
| K261824 | da Vinci Surgical System, Model IS5000 | NAY | Substantially Equivalent | |
| K261249 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | |
| K260695 | da Vinci Firefly Imaging System | NAY | Substantially Equivalent | |
| K253986 | da Vinci Force Feedback Instruments | NAY | Substantially Equivalent | |
| K253978 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | Substantially Equivalent | |
| K251739 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | |
| K251763 | IRISeg | QIH | Substantially Equivalent | |
| K252675 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | |
| K252069 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | |
| K251426 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | |
| K252045 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | |
| K251817 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | |
| K251227 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | |
| K252528 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | |
| K251324 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | |
| K252350 | da Vinci SP Firefly Imaging System | NAY | Substantially Equivalent | |
| K250442 | da Vinci Surgical System, IS5000 | NAY | Substantially Equivalent | |
| K251213 | Da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | |
| K251202 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | |
| K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | GCJ | Substantially Equivalent | |
| K250674 | Vessel Sealer Curved (480522) | NAY | Substantially Equivalent | |
| K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | NAY | Substantially Equivalent | |
| K250786 | SP Endoscope, 0° (430600) | NAY | Substantially Equivalent | |
| K243714 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | |
| K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | GAG | Substantially Equivalent | |
| K243582 | da Vinci SP Advanced Access Port Kit (432701) | NAY | Substantially Equivalent | |
| K243641 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | |
| K242461 | IRISeg | QIH | Substantially Equivalent | |
| K242318 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | |
| K241814 | da Vinci SP Instruments (SP1098) | NAY | Unknown | |
| K242070 | Ion Endoluminal System (IF 1000) | EOQ | Substantially Equivalent | |
| K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | NAY | Substantially Equivalent | |
| K241635 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | |
| K241360 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | |
| K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | GEI | Substantially Equivalent | |
| K240502 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | |
| K241284 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | |
| K232773 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | |
| K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | |
| K240135 | Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) | EOQ | Substantially Equivalent | |
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | Substantially Equivalent | |
| K232984 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | |
| K231798 | da Vinci SP Surgical System | NAY | Unknown | |
| K231358 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | |
| K231212 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | |
| K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | |
| K230033 | Da Vinci SP Surgical System (SP1098) | NAY | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2955842 | 3008615487 | INTUITIVE SURGICAL, INC. | 950 Kifer Road, SUNNYVALE, CA 94086 US | 2026 | |
| 3001675293 | 3001675293 | INTUITIVE SURGICAL, INC. | 1266 Kifer Road, Sunnyvale, CA 94086 US | 2026 | and 16 more, listed in full below |
| 3007531906 | 3007531906 | INTUITIVE SURGICAL, INC. | 1450 Kifer Road, Sunnyvale, CA 94086 US | 2026 | No device listings on this registration |
| 3013942591 | 3013942591 | INTUITIVE SURGICAL, INC. | 1090 Kifer Road, Sunnyvale, CA 94086 US | 2026 | |
| 3015612252 | 3015612252 | INTUITIVE SURGICAL, INC. | 3410 Central Expressway, Santa Clara, CA 95051 US | 2026 | and 19 more, listed in full below |
| 3038182369 | 3038182369 | INTUITIVE SURGICAL, INC. | 3859 Kifer Road, Santa Clara, CA 95051 US | 2026 | |
| 3015241782 | 3015241782 | Intuitive Surgical, Inc. | 4550 W Watkins Street, Phoenix, AZ 85043 US | 2026 | |
| 3018126215 | 3018126215 | Intuitive Surgical, Inc. | 1050 Kifer Road, Sunnyvale, CA 94086 US | 2026 | |
| 3022626486 | 3022626486 | Intuitive Surgical, Inc. | 3795 Data Dr, Peachtree Corners, GA 30092 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- QIHAutomated Radiological Image Processing Software
- EOQBronchoscope (Flexible Or Rigid)
- LKFCannula, Manipulator/Injector, Uterine
- OWNConfocal Optical Imaging
- KKXDrape, Surgical, Antimicrobial
- ERYDrape, Surgical, Ent
- PUIDrape, Surgical, Exempt
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FDSGastroscope And Accessories, Flexible/Rigid
- LFLInstrument, Ultrasonic Surgical
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- FDELaparoscopy Kit
- GCILaryngoscope, Endoscope
- NTNLed Light Source
- FCWLight Source, Fiberoptic, Routine
- EQHSource, Carrier, Fiberoptic Light
- FOXStand, Infusion
- GDWStaple, Implantable
- GAGStapler, Surgical
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- LLZSystem, Image Processing, Radiological
- NAYSystem, Surgical, Computer Controlled Instrument
- IZISystem, X-Ray, Angiographic
- GEHUnit, Cryosurgical, Accessories
- NVEWasher, Cleaner, Automated, Endoscope
Recall records
Showing 25 of 277| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2310-2026 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system | Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope. | Class II | Open, Classified | |
| Z-2521-2026 | Da Vinci ASSY, PSS, SP1098, Part Number: 380601 | Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding. | Class II | Open, Classified | |
| Z-2046-2026 | Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument | Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. | Class II | Open, Classified | |
| Z-1855-2026 | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | Class I | Open, Classified | |
| Z-1355-2026 | da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 | Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality. | Class II | Open, Classified | |
| Z-1096-2026 | da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box) | Access Port System tray may develop cracks potentially resulting in a sterility breach. | Class II | Open, Classified | |
| Z-1701-2026 | Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | Class II | Open, Classified | |
| Z-1700-2026 | Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | Class II | Open, Classified | |
| Z-1699-2026 | Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA | Due to increased complaints for broken/frayed grip cables for reusable instruments. | Class II | Open, Classified | |
| Z-1698-2026 | Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA | Due to increased complaints for broken/frayed grip cables for reusable instruments. | Class II | Open, Classified | |
| Z-1697-2026 | Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA | Due to increased complaints for broken/frayed grip cables for reusable instruments. | Class II | Open, Classified | |
| Z-1696-2026 | Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A | Due to increased complaints for broken/frayed grip cables for reusable instruments. | Class II | Open, Classified | |
| Z-1134-2026 | Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A | Due to probe bags that may have a compromised or incomplete sterile pouch seal. | Class II | Open, Classified | |
| Z-1428-2026 | Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery. | An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor. | Class II | Open, Classified | |
| Z-1232-2026 | Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument | Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction | Class II | Open, Classified | |
| Z-2722-2026 | da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 | Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall. | Class II | Open, Classified | |
| Z-1325-2025 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A | Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed | Class II | Open, Classified | |
| Z-0883-2025 | 8MM,FORCE BIPOLAR,IS4000 REF 471405 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Class II | Open, Classified | |
| Z-0882-2025 | 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Class II | Open, Classified | |
| Z-0881-2025 | 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Class II | Open, Classified | |
| Z-0880-2025 | 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Class II | Open, Classified | |
| Z-0879-2025 | 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Class II | Open, Classified | |
| Z-0878-2025 | 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Class II | Open, Classified | |
| Z-0877-2025 | 8MM,COBRA GRASPER,IS4000 REF 471190 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Class II | Open, Classified | |
| Z-0876-2025 | 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain