FDA Product Code
FDA Product Code ODC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 72 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252933 | DYNE PORT | Dyne Medical Group, Inc. | 2026-06-12 | Traditional | PDF ↗ |
| K250145 | Biopsy Port Adapter | Endosound, Inc. | 2025-10-17 | Traditional | PDF ↗ |
| K252910 | Orca Air/Water and Suction Valves | Boston Scientific | 2025-10-09 | Special | PDF ↗ |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | Olympus Medical Systems Corporation | 2025-07-16 | Traditional | PDF ↗ |
| K250732 | Disposable Endoscopy Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2025-06-20 | Traditional | PDF ↗ |
| K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation | 2025-03-19 | Traditional | PDF ↗ |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | 2025-02-20 | Special | PDF ↗ |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | STERIS Corporation | 2024-11-08 | Special | PDF ↗ |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | 2024-10-11 | Special | PDF ↗ |
| K241285 | Disposable Endoscope Valves Set (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-10-01 | Traditional | PDF ↗ |
| K232067 | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector | Medivators (A Subsidiary of Steris Corporation) | 2024-03-22 | Traditional | PDF ↗ |
| K232327 | Endorail | Endostart S.R.L. | 2024-03-15 | Traditional | PDF ↗ |
| K232004 | Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector | Medivators (A Subsidiary of Steris Corporation) | 2024-03-06 | Traditional | PDF ↗ |
| K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | STERIS Corporation | 2024-03-06 | Special | PDF ↗ |
| K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | 2024-02-09 | Special | PDF ↗ |
| K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter | Medivators (A Subsidiary of Steris Corporation) | 2023-12-21 | Traditional | PDF ↗ |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | Pentax of America, Inc. | 2023-12-01 | Traditional | PDF ↗ |
| K232244 | Disposable Endoscope Valves System | Changzhou Endoclean Medical Device Co., Ltd. | 2023-11-29 | Traditional | PDF ↗ |
| K222499 | Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023-11-22 | Traditional | PDF ↗ |
| K232951 | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) | Steris | 2023-10-20 | Special | PDF ↗ |
| K232118 | ANDORATE® Valve Kit | Ga Health Company Limited | 2023-10-16 | Traditional | PDF ↗ |
| K220884 | Disposable Endoscope Valve Sets | Sml Med-Tech Solutions Limited | 2023-01-17 | Traditional | PDF ↗ |
| K222980 | Pentax Medical Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-11-21 | Traditional | PDF ↗ |
| K221331 | Disposable Endoscope Valves System | Changzhou Endoclean Medical Device Co., Ltd. | 2022-09-08 | Traditional | PDF ↗ |
| K220210 | Disposable Endoscopy Adapter Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-06-17 | Traditional | PDF ↗ |
| K221264 | FROG Forceps Valve (VAL1-F1-100) | Fujifilm Medwork GmbH | 2022-06-01 | Special | PDF ↗ |
| K213483 | SnapLoc Wire Lock | Wilson Cook Medical | 2022-04-26 | Traditional | PDF ↗ |
| K220247 | Guidewire Locking Device | Micro-Tech (Nanjing) Co., Ltd. | 2022-03-29 | Traditional | PDF ↗ |
| K211814 | Wellead Endoscopic Seal | Well Lead Medical Co., Ltd. | 2022-01-14 | Traditional | PDF ↗ |
| K213095 | andorate Suction Valve, andorate Air/Water Valve | Ga Health Company Limited | 2022-01-12 | Traditional | PDF ↗ |
| K210625 | JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve | Fujifilm Medwork GmbH | 2021-09-10 | Traditional | PDF ↗ |
| K210342 | BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor | STERIS Corporation | 2021-09-03 | Traditional | PDF ↗ |
| K210353 | AutoCap RX | Boston Scientific Corporation | 2021-05-06 | Traditional | PDF ↗ |
| K202104 | BioGuard EUS Air/Water and Suction Valves | STERIS Corporation | 2021-01-14 | Traditional | PDF ↗ |
| K203630 | BioGuard Air/Water and Suction Valves | Steris Corporations | 2021-01-08 | Special | PDF ↗ |
| K200769 | Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B | Wilson Instruments (Sha) Co., Ltd. | 2021-01-06 | Traditional | PDF ↗ |
| K202237 | Locking device | Hangzhou AGS MedTech Co., Ltd. | 2020-12-23 | Traditional | PDF ↗ |
| K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve | Ga Health Company Limited | 2020-06-24 | Traditional | PDF ↗ |
| K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | Ga Health Company Limited | 2020-06-18 | Traditional | PDF ↗ |
| K192048 | Single Use Endoscope Valves Set | Anrei Medical (Hangzhou) Co., Ltd. | 2020-05-14 | Traditional | PDF ↗ |
| K192258 | Disposable Valve Sets | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2019-12-30 | Traditional | PDF ↗ |
| K192059 | Bio Guard Air/Water & Suction Valves | United States Endoscopy Group, Inc. | 2019-09-17 | Special | PDF ↗ |
| K191231 | Andorate Auxiliary Water Connector, Andorate Valves Set | Smartdata Suzhou Co., Ltd. | 2019-06-07 | Traditional | PDF ↗ |
| K190164 | CleverLock Guidewire Locking Device and Biopsy Cap | Olympus Surgical Technologies America | 2019-04-04 | Traditional | PDF ↗ |
| K181712 | San Antonio Stopcock | Cook Incorporated | 2018-07-26 | Traditional | PDF ↗ |
| K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter | Cook Incorporated | 2018-03-22 | Traditional | PDF ↗ |
| K162142 | Accessory Irrigation Adapter | Wilson-Cook Medical, Inc. | 2017-04-27 | Traditional | PDF ↗ |
| K160403 | SmartStart Air/Water and Suction Valves | Endochoice, Inc. | 2016-05-19 | Traditional | PDF ↗ |
| K151714 | Disposable Endoscope Valves Set A | Wilson Instruments (Shanghai) Company Limited | 2015-12-03 | Traditional | PDF ↗ |
| K151345 | BioGuard Air/Water Valve, BioGuard Suction Valve | United States Endoscopy Group, Inc. | 2015-08-25 | Traditional | PDF ↗ |
| K112698 | CONCENTRIC BALLOON GOOGLE | United States Endoscopy Group, Inc. | 2012-05-18 | Traditional | PDF ↗ |
| K112106 | NAVIAID ICVI-F,S,B,R DEVICE | Smart Medical Systems , Ltd. | 2012-02-06 | Traditional | PDF ↗ |
| K103155 | SUMO ACCESS AND TISSUE RESECTION SYSTEM | Apollo Endosurgery, Inc. | 2011-10-28 | Traditional | PDF ↗ |
| K111760 | NAVIAID(TM) BGC DEVICE | Smart Medical Systems , Ltd. | 2011-08-09 | Special | PDF ↗ |
| K110291 | NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE | Smart Medical Systems , Ltd. | 2011-06-17 | Special | PDF ↗ |
| K110088 | DEFENDO Y-OPSY IRRIGATOR | Byrne Medical Incorporated | 2011-06-10 | Traditional | PDF ↗ |
| K102581 | DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 | Byrne Medical, Inc. | 2010-11-08 | Traditional | PDF ↗ |
| K102409 | DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 | Byrne Medical, Inc. | 2010-11-04 | Traditional | PDF ↗ |
| K101094 | CLEARJET | Easyglide , Ltd. | 2010-05-17 | Traditional | PDF ↗ |
| K093329 | SCOPE INTRODUCER MODEL 7400 | N.M. Beale Co., Inc. | 2010-02-16 | Traditional | PDF ↗ |
| K090851 | DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) | Byrne Medical, Inc. | 2009-07-02 | Traditional | PDF ↗ |
| K080764 | SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 | Max Endoscopy, Inc. | 2008-05-06 | Traditional | PDF ↗ |
| K073484 | ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 | Ethicon Endo-Surgery, Inc. | 2008-03-10 | Traditional | PDF ↗ |
| K073507 | ANCHORAGE ACCESS KIT | Epitek, Inc. | 2008-03-05 | Traditional | PDF ↗ |
| K024301 | LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT | Lsi Solutions | 2003-03-24 | Traditional | PDF ↗ |
| K010610 | RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 | Boston Scientific Corp | 2001-03-27 | Special | PDF ↗ |
| K970110 | BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) | Bard Medical Div. | 1997-02-19 | Traditional | PDF ↗ |
| K920030 | SURESEAL ENDOSCOPIC VALVE | Applied Urology, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K915719 | ANGEION ENDOSCOPIC VALVE SEAL | Angeion Corp. | 1992-02-18 | Traditional | PDF ↗ |
| K884097 | MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES | Circon Acmi | 1989-04-17 | Traditional | PDF ↗ |
| K862107 | PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR | Penn Medical Devices, Inc. | 1986-09-11 | Traditional | PDF ↗ |
| K800962 | M.R. ASSOC. WASHING TUBE/MEASURING TUBE | Mr Associates, Inc. | 1980-05-08 | Traditional | PDF ↗ |
Product code ODC · Class II · Gastroenterology, Urology. Data: openFDA.