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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 26, 2025 | K251986 | AUXILIARY WATER TUBE MAJ-855 Olympus Medical Systems Corporation, JP | OCX |
| Sep 25, 2025 | K251997 | Single-Use Biopsy Valve (MAJ-1555) Olympus Medical Systems Corporation, JP | OCX |
| May 22, 2025 | K242586 | ArgoCap (200.52) Ovesco Endoscopy AG, DE | OCX |
| Mar 20, 2025 | K241704 | Endoscopic Water Pump Hangzhou AGS MedTech Co., Ltd., CN | OCX |
| Oct 7, 2024 | K242357 | Water Container (MAJ-901); Water Container (MAJ-902) Olympus Medical Systems Corporation, JP | OCX |
| Sep 24, 2024 | K241874 | Aspiration Catheter (2189) Hobbs Medical, Inc. | OCX |
| Aug 20, 2024 | K242134 | ClearCap Distal Attachment Finemedix Co., Ltd., KR | OCX |
| May 21, 2024 | K233442 | troCarWash System Biotex, Inc. | OCX |
| Nov 21, 2023 | K230773 | Endoscopy Irrigation Tubing Zhejiang Chuangxiang Medical Technology Co., Ltd., CN | OCX |
| Sep 8, 2023 | K231471 | Air/Water Bottle Tubing, CO2 Source Tubing Zhejiang Chuangxiang Medical Technology Co., Ltd., CN | OCX |
| Aug 14, 2023 | K231418 | ENDOGATOR Hybrid Irrigation Tubing Medivators | OCX |
| Aug 1, 2023 | K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing Ga Health Company Limited, HK | OCX |
| Jul 7, 2023 | K230932 | ANDORATE® Valve Kit Ga Health Company Limited, CN | OCX |
| Feb 27, 2023 | K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) Saneso, Inc. | OCX |
| Feb 17, 2023 | K222695 | troCarWash System Biotex, Inc. | OCX |
| Nov 10, 2022 | K223171 | AquaPulse® Irrigation Tubing Ga Health Company Limited, CN | OCX |
| Nov 8, 2022 | K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing Diversatek Healthcare | OCX |
| Oct 7, 2022 | K221310 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing Changzhou Endoclean Medical Device Co., Ltd., CN | OCX |
| Sep 27, 2022 | K220785 | Clean Connecting Tube Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | OCX |
| Aug 19, 2022 | K221824 | OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00- Cipher Surgical Limited, GB | OCX |
| Aug 11, 2022 | K221177 | Erbe's Tubing/Cap Sets Erbe USA, Inc. | OCX |
| Oct 20, 2021 | K210618 | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series Chongqing Jinshan Science & Technology Co., Ltd., CN | OCX |
| Sep 29, 2021 | K203350 | ENDOtube Nissha Medical Technologies Sas, FR | OCX |
| Feb 19, 2021 | K202616 | ClearCap Distal Attachment Finemedix Co., Ltd., KR | OCX |
| Dec 10, 2020 | K202560 | AquaPulse Irrigation Tubing Ga Health Company Limited, CN | OCX |
| May 15, 2020 | K200479 | AquaPulse Auxiliary Water Connector Ga Health Company Limited, CN | OCX |
| Apr 14, 2020 | K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector Ga Health Company Limited, CN | OCX |
| Apr 6, 2020 | K193250 | Irrigation Tubing with CO2 or Air Keymed (Medical and Industrial Equipment) , Ltd., GB | OCX |
| Nov 22, 2019 | K193036 | C2 CryoBalloon EndoGrip Pentax Medical, A Division of Pentax of America, Inc. | OCX |
| Sep 6, 2019 | K191366 | Vacutore Air/Water Bottle Tubing Smartdata Suzhou Co., Ltd., CN | OCX |
| Jul 11, 2019 | K181457 | EndoStream(TM) Partnership Medical Limited, GB | OCX |
| Jul 11, 2019 | K181418 | ScopeFlow Pure(TM) Partnership Medical Limited, GB | OCX |
| Jun 27, 2019 | K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector Erbe USA, Inc. | OCX |
| May 23, 2019 | K190469 | ERBEFLO 2 Disposable Tubing System Erbe USA, Inc. | OCX |
| Apr 17, 2019 | K182998 | Andorate Auxiliary Water Connector Smartdata Suzhou Co., Ltd., CN | OCX |
| Feb 1, 2019 | K182319 | Glo-Tip Spray Catheter Wilson-Cook Medical, Inc. | OCX |
| Nov 6, 2018 | K182444 | ERBEFLO Olympus Scope Port Connector Erbe USA, Inc. | OCX |
| Sep 13, 2018 | K182275 | Seal Single Use Biopsy Valve Boston Scientific Corporation | OCX |
| Jul 6, 2018 | K181509 | Endorate Valve Sets Smartdata Suzhou Co., Ltd., CN | OCX |
| May 14, 2018 | K173758 | Disposable Biopsy Valve Zhejiang Chuangxiang Medical Technology Co., Ltd., CN | OCX |
| Feb 26, 2018 | K171637 | OpClear System Cipher Surgical, Ltd., GB | OCX |
| May 26, 2016 | K161167 | Seal Single-Use Biopsy Valve Endochoice, Inc. | OCX |
| Feb 9, 2016 | K152278 | ENDOFLOW II - Irrigation, Warming and Suction System Promepla Sam, MC | OCX |
| Oct 13, 2015 | K152140 | Boa Endoscopic Valve C2 Therapeutics, Inc. | OCX |
| Mar 10, 2015 | K142068 | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE Medovations, Inc. | OCX |
| Dec 18, 2014 | K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector Erbe USA, Inc. | OCX |
| Jul 15, 2014 | K140753 | ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM Medivators | OCX |
| Apr 4, 2014 | K140315 | US ENDOSCOPY DISTAL ATTACHMENT CAP United States Endoscopy Group, Inc. | OCX |
| Mar 19, 2014 | K133734 | SEAL SINGLE-USE BIOPSY VALVE Endochoice, Inc. | OCX |
| Mar 12, 2014 | K140405 | TORRENT IRRIGATION SYSTEM United States Endoscopy Group, Inc. | OCX |
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