Panels › Gastroenterology, Urology › Product code OCX · Class 2
Endoscopic Irrigation/Suction System
Regulation 876.1500
0510(k)s in 12 months (93 all time)
2recalls in 12 months (18 all time)
18recalls that name a 510(k)
Top companies in OCX
| Company | 510(k)s | Recalls |
|---|---|---|
| Ga Health Company Limited | 6 | 11 |
| Erbe USA, Inc. | 6 | 0 |
| Byrne Medical, Inc. | 5 | 0 |
| Hobbs Medical, Inc. | 3 | 2 |
| Endochoice, Inc. | 4 | 0 |
| United States Endoscopy Group, Inc. | 4 | 0 |
| KARL STORZ Endoscopy-America, Inc. | 3 | 0 |
| Olympus Medical Systems Corporation | 3 | 0 |
| Smartdata Suzhou Co., Ltd. | 3 | 0 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Erbe Medical, LLC ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 Open, Classified |
OCX | K190469 |
| May 1, 2026 | Erbe Medical, LLC ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203; Open, Classified |
OCX | K221177 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm
Disposable For endoscopy procedures
Ref: 2191 Open, Classified |
OCX | K030765 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm
Disposable For endoscopy procedures
Ref: 2190 Open, Classified |
OCX | K030765 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED ScopeValet Guardian Disposable Endoscope Valves Set-
Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector
Product Code: 345SVVO4 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501
Product Code: 345SVVO1 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector
Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA
Product Code: 1203-72 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve
Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA
Product Code: 1203-71 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus
Product Code: GAR3846 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector
Product Code: GAR046 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve
Product Code: GAR004 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED STOPCON Suction Valve-Suction Valve for GI-Endoscope
DISTRIBUTED BY: KEY SURGICAL
8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA
Product Code: EN10232 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction)
DISTRIBUTED BY: KEY SURGICAL
8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA
Product Code: EN10229.2 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector)
DISTRIBUTED BY: KEY SURGICAL
8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA
Product C Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve)
DISTRIBUTED BY: KEY SURGICAL
8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA
Product Code Terminated |
OCX | K181509 K182998 |
| Jul 1, 2015 | US Endoscopy Group Inc 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 Velo Terminated |
OCX | K092461 |
| Jan 26, 2015 | Baxter Healthcare Corp. Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC
Plastic Containers, Approximate Length 85" (2.2 m) Terminated |
OCX | K960787 |
| Apr 11, 2013 | US Endoscopy Group Inc 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 irrig Terminated |
OCX | K103239 |
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