Gyrus ACMI, Inc.
Bartlett, TN, US
GYRUS ACMI, INC. appears in FDA device records in Bartlett, TN. FDA records list 67 510(k) clearances between and , 38 PMA records and 5 registered establishments. As of , FDA records show 39 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Gyrus ACMI, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Gyrus Acmi, Incorporatedenforcement report, recall
- Gyrus Medical, Inc.registration, 510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 67FDA records hold 67 510(k) clearances for Gyrus ACMI, Inc. between 1990 and 2026. The busiest year on record is 2003, with 8. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1999 | 4 |
| 2000 | 2 |
| 2002 | 3 |
| 2003 | 8 |
| 2004 | 2 |
| 2005 | 3 |
| 2007 | 1 |
| 2008 | 5 |
| 2009 | 4 |
| 2010 | 4 |
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 5 |
| 2017 | 2 |
| 2018 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | GEI | Substantially Equivalent | |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) | FGB | Substantially Equivalent | |
| K231327 | POWERSEAL Sealer and Divider | GEI | Substantially Equivalent | |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories | GEX | Substantially Equivalent | |
| K212650 | Celeris, Disposable Sinus Debrider | ERL | Substantially Equivalent | |
| K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle | GEI | Substantially Equivalent | |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | GEX | Substantially Equivalent | |
| K181696 | ChitoZolve | LYA | Substantially Equivalent | |
| K180086 | Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter | FGE | Substantially Equivalent | |
| K171440 | Berkeley VC-10 Vacuum Curettage System | HHI | Substantially Equivalent | |
| K170908 | PK AIM | GEI | Substantially Equivalent | |
| K163373 | PK AIM | GEI | Substantially Equivalent | |
| K161038 | PK Morcellator | GEI | Substantially Equivalent | |
| K161825 | PK AIM | GEI | Substantially Equivalent | |
| K152744 | DIEGO ELITE DRILL | ERL | Substantially Equivalent | |
| K152531 | InstaClear Lens Cleaner | EOB | Substantially Equivalent | |
| K152219 | PK AIM | GEI | Substantially Equivalent | |
| K142759 | PK Cutting Forceps for ESG-400 Workstation | GEI | Substantially Equivalent | |
| K142350 | PK J-HOOK | GEI | Substantially Equivalent | |
| K142289 | PK Spatula | GEI | Substantially Equivalent | |
| K142154 | PK NEEDLE | GEI | Substantially Equivalent | |
| K132383 | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER | LJE | Substantially Equivalent | |
| K123429 | OLYMPUS ENERGY POWER SYSTEM (EPS) | GEI | Substantially Equivalent | |
| K122605 | PKS BILL | HIN | Substantially Equivalent | |
| K121678 | DTAD | ERL | Substantially Equivalent | |
| K120474 | GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY | KCT | Substantially Equivalent | |
| K120567 | GYRUS AMCI PK BUTTON ELECTRODE | FAS | Substantially Equivalent | |
| K111059 | GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) | HIN | Substantially Equivalent | |
| K110852 | DOLPHIN 3 FLUID MANAGEMENT SYSTEM | HIG | Substantially Equivalent | |
| K102970 | GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT | KCT | Substantially Equivalent | |
| K092571 | GYRUS ACMI BIOCOAG PROBE | KNS | Substantially Equivalent | |
| K100816 | PK SUPERPULSE SYSEM GENERATOR MODEL 744000 | GEI | Substantially Equivalent | |
| K100896 | GYRUS ACMI HALO PKS CUTTING FORCEPS | GEI | Substantially Equivalent | |
| K093181 | GYRUS ACMI PK BUTTON ELECTRODE | FAS | Substantially Equivalent | |
| K092682 | GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS | KCT | Substantially Equivalent | |
| K092278 | GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 | HIH | Substantially Equivalent | |
| K080844 | G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE | GEI | Substantially Equivalent | |
| K090814 | MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 | FAJ | Substantially Equivalent | |
| K083013 | PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 | GEI | Substantially Equivalent | |
| K081766 | PKS OMNI INSTRUMENT | GEI | Substantially Equivalent | |
| K082054 | GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 | GEI | Substantially Equivalent | |
| K081954 | GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE | GEI | Substantially Equivalent | |
| K080093 | PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK | GEI | Substantially Equivalent | |
| K072594 | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM | FGA | Substantially Equivalent | |
| K050550 | GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | |
| K050460 | GYRUS PLASMACISION AND PLASMABLEND ELECTRODES | GEI | Substantially Equivalent | |
| K041999 | GYRUS PLASMA SKIN RESURFACING SYSTEM | GEI | Substantially Equivalent | |
| K041633 | GYRUS PLASMACISION LAPAROSCOPIC SPATULA | GEI | Substantially Equivalent | |
| K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | GEI | Substantially Equivalent | |
| K024286 | GYRUS OPEN FORCEPS | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1037007 | 1037007 | GYRUS ACMI, INC. | 2925 Appling Rd, BARTLETT, TN 38133 US | 2026 | and 21 more, listed in full below |
| 3003790304 | 3003790304 | GYRUS ACMI, INC. | 800 West Park Drive, Westborough, MA 01581 US | 2026 | and 73 more, listed in full below |
| 9617070 | 3002807134 | GYRUS MEDICAL LTD. | FORTRAN RD., ST. MELLONS, CARDIFF Wales CF3 0LT GB | 2026 | and 2 more, listed in full below |
| 3004450998 | 3004450998 | Gyrus ACMI, Inc. | 6675 185th Avenue NE, Redmond, WA 98052 US | 2026 | |
| 3011050570 | 3011050570 | Gyrus ACMI, Inc. | 9600 Louisiana Ave North, Brooklyn Park, MN 55445 US | 2026 | and 146 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEBAccessories, Cleaning, For Endoscope
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- EMXBalloon, Epistaxis
- FCGBiopsy Needle
- EOQBronchoscope (Flexible Or Rigid)
- EQJBur, Ear, Nose And Throat
- EYBCatheter, Ureteral, Gastro-Urology
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FDFColonoscope And Accessories, Flexible/Rigid
- FAJCystoscope And Accessories, Flexible/Rigid
- FBOCystourethroscope
- EZNDilator, Catheter, Ureteral
- FFLDislodger, Stone, Basket, Ureteral, Metal
- FGODislodger, Stone, Flexible
- DXJDisplay, Cathode-Ray Tube, Medical
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- FDTDuodenoscope And Accessories, Flexible/Rigid
- FASElectrode, Electrosurgical, Active, Urological
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FDXEndoscopic Cytology Brush
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FDAEnteroscope And Accessories
- FCLForceps, Biopsy, Non-Electric
- FDSGastroscope And Accessories, Flexible/Rigid
- FFSImage, Illumination, Fiberoptic, For Endoscope
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- FGAKit, Nephroscope
- CCWLaryngoscope, Rigid
- FCWLight Source, Fiberoptic, Routine
- FCRLight Source, Photographic, Fiberoptic
- FSTLight, Surgical, Fiberoptic
- FSQLight, Surgical, Instrument
- FFKLithotriptor, Electro-Hydraulic
- FEOLithotriptor, Ultrasonic
- ELWMaterial, Impression
- EWYMediastinoscope, Surgical
- ETCMold, Middle-Ear
- EOBNasopharyngoscope (Flexible Or Rigid)
- ETBProsthesis, Partial Ossicular Replacement
- BTAPump, Portable, Aspiration (Manual Or Powered)
- ETAReplacement, Ossicular Prosthesis, Total
- FJLResectoscope
- FDCResectoscope, Working Element
- FNSRing Cutter
- EWASet, Audiometer Calibration
- FDISnare, Flexible
- EPYSpeculum, Ent
- EPPSplint, Nasal
- FADStent, Ureteral
- FGEStents, Drains And Dilators For The Biliary Ducts
- ETNStimulator, Nerve
- DWXStripper, Artery, Intraluminal
- EYAStylet, Ureteral
- EPWSupport, Head, Surgical, Ent
- FSMTray, Surgical, Instrument
- ETDTube, Tympanostomy
- FGBUreteroscope And Accessories, Flexible/Rigid
- EZOUrethrotome
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 39| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1187-2019 | Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Class II | Terminated | |
| Z-1186-2019 | Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Class II | Terminated | |
| Z-1185-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Class II | Terminated | |
| Z-1184-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Class II | Terminated | |
| Z-1183-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Class II | Terminated | |
| Z-1182-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Class II | Terminated | |
| Z-1181-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Class II | Terminated | |
| Z-1180-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Class II | Terminated | |
| Z-1179-2019 | Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Class II | Terminated | |
| Z-1178-2019 | Olympus Diego Elite Console MDCONS 100 | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Class II | Terminated | |
| Z-1952-2018 | Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes. | There is a potential for the cord to spark and cause a fire. | Class II | Terminated | |
| Z-1337-2018 | Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system | "Chattering" when cutting burrs are used in bone. | Class II | Open, Classified | |
| Z-1753-2015 | Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO | Potential lack of sterility assurance. | Class II | Terminated | |
| Z-1752-2015 | Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO | Potential lack of sterility assurance. | Class II | Terminated | |
| Z-0419-2015 | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception). | All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection. | Class II | Terminated | |
| Z-0100-2015 | GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures. | Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. | Class II | Terminated | |
| Z-2269-2014 | Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands. | Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator. | Class II | Terminated | |
| Z-1196-2014 | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception). | Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen. | Class II | Terminated | |
| Z-1983-2013 | GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures. | On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life. | Class II | Terminated | |
| Z-1439-2013 | GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear. | lack of sterility assurance | Class II | Terminated | |
| Z-0411-2013 | PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube | One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer. | Class II | Terminated | |
| Z-2383-2011 | Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures. | Gyrus ACMI, Inc. wants to bring a recall issue to their customers attention concerning one lot of their 25BX-PTFE Coated 3 cm Flexible Tip Guidewire. As a result of a manufacturing error in the production this lot of guidewires, some units of product were loaded in the dispenser backwards. In such cases, the stiff end of the guidewire would be dispensed from the product first and, if undetected, could be inserted into the patient. Depending on the specific clinical circumstances of the patient, this could potentially cause perforation of the ureter and surrounding anatomy. Therefore Gyrus ACMI has chosen, out of an abundance of caution, to conduct a voluntary recall of this lot of product. | Terminated | ||
| Z-2651-2010 | GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK | Lack of sterility assurance due to compromised package seals. | Terminated | ||
| Z-2436-2010 | The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile, ready -to -use, single- use procedure tray. | Gyrus Medical, Inc. has issued a Urgent Medical Device Recall for the Gyrus ACMI product 004942-903 - Pleatman Sac Tissue Removal System, sold as lot 186540FC with an expiration date of 06/2015. As a result of a manufacturing error in the production of the trays used in this lot, it is possible that a crack could form that would compromise the package integrity, and possibly the sterility of the packaged device. | Terminated | ||
| Z-0797-2010 | MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear. | Units of the product in lot MH136952 may have been shipped without being sterilized. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain