# United States Endoscopy Group, Inc.

- Location (FDA's records): Mentor, OH
- FDA decisions: 94 (1991–2020): 94 510(k) clearances
- Product codes: GCJ (11), FDI (10), KNT (6), FEQ (6), GEI (5), OCX (4), FCK (4), FDX (4), FED (4), KNS (3), ODC (3), KGE (2)
- 510(k) review time since 2016: median 41 days, against 78 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 13 (5 its own); citations of its devices by later devices: 55 (5 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Byrne Medical, Inc.: 3 (https://510kreport.com/company/byrne-medical)
- Spirus Medical, Inc.: 2 (https://510kreport.com/company/spirus-medical)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)
- Helix Medical, Inc.: 1 (https://510kreport.com/company/helix-medical)
- Olympus Corp.: 1 (https://510kreport.com/company/olympus)

## Firms that cite its devices most
- STERIS Corporation: 6 (https://510kreport.com/company/steris)
- Endochoice, Inc.: 3 (https://510kreport.com/company/endochoice)
- Diversatek Healthcare: 3 (https://510kreport.com/company/diversatek-healthcare)
- Davol Inc., Sub. C. R. Bard, Inc.: 2 (https://510kreport.com/company/davol-sub-c-r-bard)
- Finemedix Co., Ltd.: 2 (https://510kreport.com/company/finemedix)
- Spirus Medical, Inc.: 2 (https://510kreport.com/company/spirus-medical)
- Byrne Medical, Inc.: 2 (https://510kreport.com/company/byrne-medical)
- Oridion Medical 1987, Ltd.: 2 (https://510kreport.com/company/oridion-medical-1987)

## Its most-cited devices
- K040836: Disposable Overtube (2004), cited by 10
- K070420: Bioshield-Ercp Biopsy Valve, Model 00711138 (2007), cited by 4
- K971842: Coaxial Needle (1997), cited by 2
- K040961: Injector Needle/Snare (2004), cited by 2
- K103239: Irrigation System (2010), cited by 2
- K101146: Water Bottle Cap System (2010), cited by 2

## Recent decisions
- K192265: gi-4000 Electrosurgical Generator (May 21, 2020)
- K200745: Lariat, Hot/Cold Snare (Apr 21, 2020)
- K192059: Bio Guard Air/Water & Suction Valves (Sep 17, 2019)
- K191559: AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM (Aug 1, 2019)
- K182909: Roth Net Retriever Product Line (Nov 21, 2018)
- K182258: AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm (Sep 21, 2018)
- K173650: AquaShield System CO2- Fujifilm (Jan 5, 2018)
- K172805: gi-4000 Electrosurgical Generator (Oct 23, 2017)

Source page: https://510kreport.com/company/united-states-endoscopy-group