FDA Product Code
FDA Product Code OCX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 93 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251986 | AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation | 2025-09-26 | Traditional | PDF ↗ |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | 2025-09-25 | Traditional | PDF ↗ |
| K242586 | ArgoCap (200.52) | Ovesco Endoscopy AG | 2025-05-22 | Traditional | PDF ↗ |
| K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. | 2025-03-20 | Traditional | PDF ↗ |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | Olympus Medical Systems Corporation | 2024-10-07 | Traditional | PDF ↗ |
| K241874 | Aspiration Catheter (2189) | Hobbs Medical, Inc. | 2024-09-24 | Traditional | PDF ↗ |
| K242134 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2024-08-20 | Special | PDF ↗ |
| K233442 | troCarWash System | Biotex, Inc. | 2024-05-21 | Traditional | PDF ↗ |
| K230773 | Endoscopy Irrigation Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-11-21 | Traditional | PDF ↗ |
| K231471 | Air/Water Bottle Tubing, CO2 Source Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-09-08 | Traditional | PDF ↗ |
| K231418 | ENDOGATOR Hybrid Irrigation Tubing | Medivators | 2023-08-14 | Traditional | PDF ↗ |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | Ga Health Company Limited | 2023-08-01 | Traditional | PDF ↗ |
| K230932 | ANDORATE® Valve Kit | Ga Health Company Limited | 2023-07-07 | Traditional | PDF ↗ |
| K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | Saneso, Inc. | 2023-02-27 | Traditional | PDF ↗ |
| K222695 | troCarWash System | Biotex, Inc. | 2023-02-17 | Traditional | PDF ↗ |
| K223171 | AquaPulse® Irrigation Tubing | Ga Health Company Limited | 2022-11-10 | Special | PDF ↗ |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing | Diversatek Healthcare | 2022-11-08 | Traditional | PDF ↗ |
| K221310 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | Changzhou Endoclean Medical Device Co., Ltd. | 2022-10-07 | Traditional | PDF ↗ |
| K220785 | Clean Connecting Tube | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-09-27 | Traditional | PDF ↗ |
| K221824 | OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315 | Cipher Surgical Limited | 2022-08-19 | Special | PDF ↗ |
| K221177 | Erbe's Tubing/Cap Sets | Erbe USA, Inc. | 2022-08-11 | Traditional | PDF ↗ |
| K210618 | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series | Chongqing Jinshan Science & Technology Co., Ltd. | 2021-10-20 | Traditional | PDF ↗ |
| K203350 | ENDOtube | Nissha Medical Technologies Sas | 2021-09-29 | Traditional | PDF ↗ |
| K202616 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2021-02-19 | Traditional | PDF ↗ |
| K202560 | AquaPulse Irrigation Tubing | Ga Health Company Limited | 2020-12-10 | Traditional | PDF ↗ |
| K200479 | AquaPulse Auxiliary Water Connector | Ga Health Company Limited | 2020-05-15 | Traditional | PDF ↗ |
| K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector | Ga Health Company Limited | 2020-04-14 | Traditional | PDF ↗ |
| K193250 | Irrigation Tubing with CO2 or Air | Keymed (Medical and Industrial Equipment) , Ltd. | 2020-04-06 | Traditional | PDF ↗ |
| K193036 | C2 CryoBalloon EndoGrip | Pentax Medical, A Division of Pentax of America, Inc. | 2019-11-22 | Special | PDF ↗ |
| K191366 | Vacutore Air/Water Bottle Tubing | Smartdata Suzhou Co., Ltd. | 2019-09-06 | Traditional | PDF ↗ |
| K181418 | ScopeFlow Pure(TM) | Partnership Medical Limited | 2019-07-11 | Traditional | PDF ↗ |
| K181457 | EndoStream(TM) | Partnership Medical Limited | 2019-07-11 | Traditional | PDF ↗ |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector | Erbe USA, Inc. | 2019-06-27 | Special | PDF ↗ |
| K190469 | ERBEFLO 2 Disposable Tubing System | Erbe USA, Inc. | 2019-05-23 | Traditional | PDF ↗ |
| K182998 | Andorate Auxiliary Water Connector | Smartdata Suzhou Co., Ltd. | 2019-04-17 | Traditional | PDF ↗ |
| K182319 | Glo-Tip Spray Catheter | Wilson-Cook Medical, Inc. | 2019-02-01 | Traditional | PDF ↗ |
| K182444 | ERBEFLO Olympus Scope Port Connector | Erbe USA, Inc. | 2018-11-06 | Traditional | PDF ↗ |
| K182275 | Seal Single Use Biopsy Valve | Boston Scientific Corporation | 2018-09-13 | Special | PDF ↗ |
| K181509 | Endorate Valve Sets | Smartdata Suzhou Co., Ltd. | 2018-07-06 | Traditional | PDF ↗ |
| K173758 | Disposable Biopsy Valve | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-05-14 | Traditional | PDF ↗ |
| K171637 | OpClear System | Cipher Surgical, Ltd. | 2018-02-26 | Traditional | PDF ↗ |
| K161167 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2016-05-26 | Special | PDF ↗ |
| K152278 | ENDOFLOW II - Irrigation, Warming and Suction System | Promepla Sam | 2016-02-09 | Traditional | PDF ↗ |
| K152140 | Boa Endoscopic Valve | C2 Therapeutics, Inc. | 2015-10-13 | Traditional | PDF ↗ |
| K142068 | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE | Medovations, Inc. | 2015-03-10 | Traditional | PDF ↗ |
| K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector | Erbe USA, Inc. | 2014-12-18 | Special | PDF ↗ |
| K140753 | ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM | Medivators | 2014-07-15 | Special | PDF ↗ |
| K140315 | US ENDOSCOPY DISTAL ATTACHMENT CAP | United States Endoscopy Group, Inc. | 2014-04-04 | Traditional | PDF ↗ |
| K133734 | SEAL SINGLE-USE BIOPSY VALVE | Endochoice, Inc. | 2014-03-19 | Special | PDF ↗ |
| K140405 | TORRENT IRRIGATION SYSTEM | United States Endoscopy Group, Inc. | 2014-03-12 | Special | PDF ↗ |
| K131426 | MEDLINE BIOPSY VALVE | Medline Industries, Inc. | 2014-02-21 | Traditional | PDF ↗ |
| K132776 | SEAL BIOPSY VALVE - REUSABLE | Endochoice, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K122417 | SCOPEVALET DISPOSABLE BIOPSY VALVE | The Ruhof Corp. | 2013-05-17 | Traditional | PDF ↗ |
| K130909 | GATEWAY ADVANAGE Y-ADAPTER | Boston Scientific Corp | 2013-05-16 | Traditional | PDF ↗ |
| K122740 | JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN | Jetprep, Ltd. | 2012-12-10 | Special | PDF ↗ |
| K112318 | CLEARPATH 24 | Promedic, Inc. | 2012-06-29 | Traditional | PDF ↗ |
| K113119 | ENDOGATOR ADVANTAGE IRRIGATION PUMP | Byrne Medical, Inc. | 2012-04-27 | Traditional | PDF ↗ |
| K111274 | JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 | Jetprep, Ltd. | 2012-04-04 | Traditional | PDF ↗ |
| K111821 | BIOPSY VALVE | Endochoice, Inc. | 2011-07-28 | Traditional | PDF ↗ |
| K103239 | IRRIGATION SYSTEM | United States Endoscopy Group, Inc. | 2010-12-30 | Traditional | PDF ↗ |
| K103235 | ERBEFLO 2 DISPOSABLE TUBING SYSTEM | Erbe USA, Inc. | 2010-12-23 | Traditional | PDF ↗ |
| K102855 | UNIVERSAL IRRIGATION SOLUTION HYBRID | Byrne Medical, Inc. | 2010-11-19 | Traditional | PDF ↗ |
| K092461 | IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 | United States Endoscopy Group, Inc. | 2009-11-05 | Traditional | PDF ↗ |
| K060962 | ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 | Byrne Medical, Inc. | 2006-04-19 | Traditional | PDF ↗ |
| K031457 | ENDOMAT LC PUMP, MODEL 20 3303 20 | KARL STORZ Endoscopy-America, Inc. | 2004-04-28 | Traditional | PDF ↗ |
| K033695 | IRRIGATION CHANNEL TUBING, MODEL 100135 | Byrne Medical, Inc. | 2003-12-23 | Traditional | PDF ↗ |
| K031773 | ENDO GATOR SYSTEM | Byrne Medical, Inc. | 2003-06-24 | Traditional | PDF ↗ |
| K030765 | HOBBS MISTIFIER SPRAY CATHETER | Hobbs Medical, Inc. | 2003-06-09 | Traditional | PDF ↗ |
| K021776 | KSEA QUADRO SWITCH | Karl Storz Endoscopy | 2002-08-15 | Traditional | PDF ↗ |
| K020614 | IRRIGATING CANNULA | Ca Guard, Ltd. | 2002-05-24 | Traditional | PDF ↗ |
| K993778 | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 | Northgate Technologies, Inc. | 2000-01-06 | Special | PDF ↗ |
| K992535 | ENDIUS SUCTION/IRRIGATION INSTRUMENT | Endius, Inc. | 1999-09-01 | Traditional | PDF ↗ |
| K971125 | ENDO SMARTCAP (100501) | Endo Smart Cap Co. | 1997-05-23 | Traditional | PDF ↗ |
| K970764 | COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES | Comeg Endoscopy | 1997-04-22 | Traditional | PDF ↗ |
| K964196 | CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) | Northgate Technologies, Inc. | 1996-12-23 | Traditional | PDF ↗ |
| K953655 | J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS | Johnson & Johnson Medical, Inc. | 1995-10-13 | Traditional | PDF ↗ |
| K942918 | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER | Tri-Med Specialties, Inc. | 1995-02-28 | Traditional | PDF ↗ |
| K934170 | ENDOMEDIX Y-ADAPTER | Endomedix | 1994-01-11 | Traditional | PDF ↗ |
| K931201 | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER | Tri-Med Specialties, Inc. | 1993-09-28 | Traditional | PDF ↗ |
| K905102 | BARD(R) SYRINGE ASSIST IRRIGATION | C.R. Bard, Inc. | 1991-04-09 | Traditional | PDF ↗ |
| K903834 | N. M. BEALE COMPANY VU-THRU WATER BOTTLE | N.M. Beale Co., Inc. | 1990-09-24 | Traditional | PDF ↗ |
| K892426 | NO. 86500 - ENDOSCOPIC JET WASHER | Superior Healthcare Group, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K891339 | IRRI-FLO IRRIGATION DELIVERY SYSTEM | Surgitek | 1989-06-02 | Traditional | PDF ↗ |
| K883173 | MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION | KARL STORZ Endoscopy-America, Inc. | 1988-10-25 | Traditional | PDF ↗ |
| K875264 | WASHING CATHETER | Endovations | 1988-03-29 | Traditional | PDF ↗ |
| K862058 | RAPID ENDOSCOPIC LAVAGE SYSTEM | Endovations | 1986-08-11 | Traditional | PDF ↗ |
| K844550 | HOBBS MEDICAL/JAYCO ASPIRATION CATHETER | Hobbs Medical, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K844691 | ENDOSCOPIC ASPIRATION CATHETER SET | Jayco Pharmaceuticals | 1985-01-02 | Traditional | PDF ↗ |
| K833331 | ASPIRATION & IRRIGATION CATHETER | Microvasive | 1983-11-14 | Traditional | PDF ↗ |
| K832009 | MODEL #27224P CONTINUOUS FLOW PUMP | KARL STORZ Endoscopy-America, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K822061 | LAVAGING CATHETERS | American Endoscopy, Inc. | 1982-07-20 | Traditional | PDF ↗ |
| K810506 | PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT | Propper Mfg. Co., Inc. | 1981-04-07 | Traditional | PDF ↗ |
| K760451 | AIR WATER SOURCE (ACMI MODEL 710) | American Cystocope Makers, Inc. | 1976-08-30 | Traditional | PDF ↗ |
Product code OCX · Class II · Gastroenterology, Urology. Data: openFDA.