United States Endoscopy Group, Inc.
Mentor, OH, US
UNITED STATES ENDOSCOPY GROUP, INC. appears in FDA device records in Mentor, OH. FDA records list 94 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to United States Endoscopy Group, 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.
- US Endoscopy Group Incenforcement report, recall
510(k) clearance history
Showing 50 of 94FDA records hold 94 510(k) clearances for United States Endoscopy Group, Inc. between 1991 and 2020. The busiest year on record is 1991, with 22. The most recent is 2020, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 22 |
| 1992 | 8 |
| 1993 | 4 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 9 |
| 1997 | 5 |
| 1999 | 1 |
| 2004 | 3 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 4 |
| 2011 | 4 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 5 |
| 2017 | 3 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192265 | gi-4000 Electrosurgical Generator | GEI | Substantially Equivalent | |
| K200745 | Lariat, Hot/Cold Snare | FDI | Substantially Equivalent | |
| K192059 | Bio Guard Air/Water & Suction Valves | ODC | Substantially Equivalent | |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM | FEQ | Substantially Equivalent | |
| K182909 | Roth Net Retriever Product Line | FDI | Substantially Equivalent | |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm | FEQ | Substantially Equivalent | |
| K173650 | AquaShield System CO2- Fujifilm | FEQ | Substantially Equivalent | |
| K172805 | gi-4000 Electrosurgical Generator | GEI | Substantially Equivalent | |
| K163495 | AdvanCE capsule endoscope delivery device | NEZ | Substantially Equivalent | |
| K163492 | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear | FDF | Substantially Equivalent | |
| K153362 | AquaShield system CO2, AquaShield system-PENTAX | FEQ | Substantially Equivalent | |
| K152035 | iSnare system-Lariat | FBK | Substantially Equivalent | |
| K151345 | BioGuard Air/Water Valve, BioGuard Suction Valve | ODC | Substantially Equivalent | |
| K151889 | Infinity ERCP Sampling Device | FDX | Substantially Equivalent | |
| K151197 | Lariat snare | FDI | Substantially Equivalent | |
| K140315 | US ENDOSCOPY DISTAL ATTACHMENT CAP | OCX | Substantially Equivalent | |
| K140405 | TORRENT IRRIGATION SYSTEM | OCX | Substantially Equivalent | |
| K131598 | ANAL RECTAL OVERTUBE | FED | Substantially Equivalent | |
| K133736 | ENDOSCOPIC SUTURE CUTTER | OCZ | Substantially Equivalent | |
| K133513 | MULTI-STAGE SNARE | FDI | Substantially Equivalent | |
| K130148 | FOREIGN BODY HOOD | FDS | Substantially Equivalent | |
| K122462 | ROTH NET RETRIEVER | FDI | Substantially Equivalent | |
| K120084 | ENDOSCOPIC RETRIEVAL DEVICE | OCZ | Substantially Equivalent | |
| K112698 | CONCENTRIC BALLOON GOOGLE | ODC | Substantially Equivalent | |
| K120123 | AQUASHIELD CO2 SYSTEM | FEQ | Substantially Equivalent | |
| K111028 | EUS BALLOON | FDF | Substantially Equivalent | |
| K103694 | TISSUE SAMPLING NEEDLE | FCG | Substantially Equivalent | |
| K103611 | UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION | FDI | Substantially Equivalent | |
| K103326 | MULTIPLE BIOPSY SYSTEM | FCK | Substantially Equivalent | |
| K103239 | IRRIGATION SYSTEM | OCX | Substantially Equivalent | |
| K103437 | US ENDOSCOPY CYTOLOGY BRUSH | FDX | Substantially Equivalent | |
| K101146 | WATER BOTTLE CAP SYSTEM | FEQ | Substantially Equivalent | |
| K100081 | ENTEROSCOPY OVERTUBE, MODEL 00712140 | FED | Substantially Equivalent | |
| K092461 | IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 | OCX | Substantially Equivalent | |
| K092221 | COLONIC SPLINTING OVERTUBE, MODEL 00711145 | FED | Substantially Equivalent | |
| K070420 | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 | ODD | Substantially Equivalent | |
| K061201 | DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 | FCK | Substantially Equivalent | |
| K051637 | DSNARE, MODEL 00711087 | FCK | Substantially Equivalent | |
| K040961 | INJECTOR NEEDLE/SNARE | FDI | Substantially Equivalent | |
| K040494 | CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 | NEZ | Substantially Equivalent | |
| K040836 | DISPOSABLE OVERTUBE | FED | Substantially Equivalent | |
| K984168 | BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE | FCF | Substantially Equivalent | |
| K972505 | RESUABLE HOT BIOPSY FORCEPS | KGE | Substantially Equivalent | |
| K971842 | COAXIAL NEEDLE | FCG | Substantially Equivalent | |
| K970945 | ANGLED TIP POLYPECTOMY SNARE | KNS | Substantially Equivalent | |
| K963051 | ERCP CANNULA | ODD | Substantially Equivalent | |
| K970356 | IRRIGATION/ASPIRATION POLYPECTOMY | FDI | Substantially Equivalent | |
| K962676 | DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE | FGO | Substantially Equivalent | |
| K962346 | PAPILLOTOME | KNS | Substantially Equivalent | |
| K961762 | REUSABLE ENDOSCOPIC ACCESSORY HANDLE | KNS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1528319 | 1000122656 | UNITED STATES ENDOSCOPY GROUP, INC. | 5976 Heisley Rd, Mentor, OH 44060 US | 2026 | and 41 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
- FEBAccessories, Cleaning, For Endoscope
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- FCGBiopsy Needle
- JXLBlock, Bite
- KDQBottle, Collection, Vacuum
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FLGCleaner, Ultrasonic, Medical Instrument
- FDFColonoscope And Accessories, Flexible/Rigid
- EYKConnector, Ureteral Catheter
- FMHContainer, Specimen, Sterile
- KNQDilator, Esophageal
- DWPDilator, Vessel, Surgical
- FGODislodger, Stone, Flexible
- NWIElectrosurgical Electrode Kit
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ODCEndoscope Channel Accessory
- NWUEndoscope Introducer Kit
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- MNKEndoscopic Bite Block
- FDXEndoscopic Cytology Brush
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- OCXEndoscopic Irrigation/Suction System
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- OCUEndoscopic Storage Cover
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- KQTEvacuator, Gastro-Urology
- KGEForceps, Biopsy, Electric
- FCLForceps, Biopsy, Non-Electric
- HCZForceps, Surgical, Gynecological
- FDSGastroscope And Accessories, Flexible/Rigid
- PKLHemostatic Metal Clip For The Gi Tract
- KNWInstrument, Biopsy
- FCFInstrument, Biopsy, Mechanical, Gastrointestinal
- FCKInstrument, Biopsy, Suction
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- MNDLigator, Esophageal
- FHNLigator, Hemorrhoidal
- GCTLight Source, Endoscope, Xenon Arc
- LQCLithotriptor, Biliary Mechanical
- NBGMarker, Colon
- FEQPump, Air, Non-Manual, For Endoscope
- FDISnare, Flexible
- FGXSnare, Non-Electrical
- FGEStents, Drains And Dilators For The Biliary Ducts
- LWGSurgical Table Cushion
- NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule
- BWNTable And Attachments, Operating-Room
- ITXTransducer, Ultrasonic, Diagnostic
- FCHTray, Biopsy, Without Biopsy Instruments
- DRCTrocar
- KNTTubes, Gastrointestinal (And Accessories)
- GEHUnit, Cryosurgical, Accessories
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1011-2019 | US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs. | Potential esophageal laceration during a patient procedure | Class II | Terminated | |
| Z-1416-2017 | Roth Net Polyp Retrieval | The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration. | Class III | Terminated | |
| Z-0289-2017 | Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes | US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products. | Class II | Terminated | |
| Z-0001-2016 | Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures. | The company has determined the sterility cannot be assured for the affected lot. | Class II | Terminated | |
| Z-1453-2015 | Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract. | A wire component on the distal grasping assembly of the device became detached.. | Class II | Terminated | |
| Z-1943-2015 | Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump. | The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use. | Class II | Terminated | |
| Z-0861-2015 | UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope. | Packaging non-conformance related to the integrity of the sterile pouch seal. | Class II | Terminated | |
| Z-1099-2013 | Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit. | The firm was notified by their customers that there was a water leakage from the white tubing connector. | Class II | Terminated | |
| Z-2396-2012 | Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract. | US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter. | Class II | Terminated | |
| Z-0006-2013 | Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract. | When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain