Endoscope Channel Accessory

FDA product code ODC · 70 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.1500
Review panel: GU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-05-08 – 2026-06-12

To give the endoscope channel additional or improved functionality.

ODC 2026-06-12

DYNE PORT

Applicant Dyne Medical Group, Inc.

K number K252933

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ODC 2025-10-17

Biopsy Port Adapter

Applicant Endosound, Inc.

K number K250145

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ODC 2025-10-09

Orca Air/Water and Suction Valves

Applicant Boston Scientific

K number K252910

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ODC 2025-07-16

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)

Applicant Olympus Medical Systems Corporation

K number K250949

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ODC 2025-06-20

Disposable Endoscopy Valve Set

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K number K250732

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ODC 2025-03-19

Luer-Split MAJ-2092

Applicant Olympus Medical Systems Corporation

K number K241842

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ODC 2025-02-20

Defendo Fujifilm 700 Single Use Cleaning Adapter

Applicant Steris Corparation

K number K250140

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ODC 2024-11-08

Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)

Applicant STERIS Corporation

K number K243075

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ODC 2024-10-11

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)

Applicant STERIS Corporation

K number K242742

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ODC 2024-10-01

Disposable Endoscope Valves Set (AF series)

Applicant Alton (Shanghai) Medical Instruments Co., Ltd.

K number K241285

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ODC 2024-03-22

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

Applicant Medivators (A Subsidiary of Steris Corporation)

K number K232067

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ODC 2024-03-15

Endorail

Applicant Endostart S.R.L.

K number K232327

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ODC 2024-03-06

Defendo Single Use Cleaning Adapter for Olympus Endoscopes

Applicant STERIS Corporation

K number K240352

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ODC 2024-03-06

Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector

Applicant Medivators (A Subsidiary of Steris Corporation)

K number K232004

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ODC 2024-02-09

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)

Applicant STERIS Corporation

K number K240098

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ODC 2023-12-21

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

Applicant Medivators (A Subsidiary of Steris Corporation)

K number K232329

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ODC 2023-12-01

PENTAX Medical Gas/Water Feeding Valve OE-B14

Applicant Pentax of America, Inc.

K number K232249

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ODC 2023-11-29

Disposable Endoscope Valves System

Applicant Changzhou Endoclean Medical Device Co., Ltd.

K number K232244

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ODC 2023-11-22

Disposable Endoscope Valves Kit

Applicant Shanghai SeeGen Photoelectric Technology Co., Ltd.

K number K222499

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ODC 2023-10-20

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)

Applicant Steris

K number K232951

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ODC 2023-10-16

ANDORATE® Valve Kit

Applicant Ga Health Company Limited

K number K232118

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ODC 2023-01-17

Disposable Endoscope Valve Sets

Applicant Sml Med-Tech Solutions Limited

K number K220884

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ODC 2022-11-21

Pentax Medical Valve Set

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K number K222980

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ODC 2022-09-08

Disposable Endoscope Valves System

Applicant Changzhou Endoclean Medical Device Co., Ltd.

K number K221331

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ODC 2022-06-17

Disposable Endoscopy Adapter Set

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K number K220210

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ODC 2022-06-01

FROG Forceps Valve (VAL1-F1-100)

Applicant Fujifilm Medwork GmbH

K number K221264

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ODC 2022-04-26

SnapLoc Wire Lock

Applicant Wilson Cook Medical

K number K213483

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ODC 2022-03-29

Guidewire Locking Device

Applicant Micro-Tech (Nanjing) Co., Ltd.

K number K220247

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ODC 2022-01-14

Wellead Endoscopic Seal

Applicant Well Lead Medical Co., Ltd.

K number K211814

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ODC 2022-01-12

andorate Suction Valve, andorate Air/Water Valve

Applicant Ga Health Company Limited

K number K213095

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ODC 2021-09-10

JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve

Applicant Fujifilm Medwork GmbH

K number K210625

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ODC 2021-09-03

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor

Applicant STERIS Corporation

K number K210342

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ODC 2021-05-06

AutoCap RX

Applicant Boston Scientific Corporation

K number K210353

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ODC 2021-01-14

BioGuard EUS Air/Water and Suction Valves

Applicant STERIS Corporation

K number K202104

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ODC 2021-01-08

BioGuard Air/Water and Suction Valves

Applicant Steris Corporations

K number K203630

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ODC 2021-01-06

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B

Applicant Wilson Instruments (Sha) Co., Ltd.

K number K200769

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ODC 2020-12-23

Locking device

Applicant Hangzhou AGS MedTech Co., Ltd.

K number K202237

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ODC 2020-06-24

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve

Applicant Ga Health Company Limited

K number K200495

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ODC 2020-06-18

Andorate Biopsy Valve, Andorate Biopsy Irrigator

Applicant Ga Health Company Limited

K number K200481

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ODC 2020-05-14

Single Use Endoscope Valves Set

Applicant Anrei Medical (Hangzhou) Co., Ltd.

K number K192048

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ODC 2019-12-30

Disposable Valve Sets

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K number K192258

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ODC 2019-09-17

Bio Guard Air/Water & Suction Valves

Applicant United States Endoscopy Group, Inc.

K number K192059

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ODC 2019-06-07

Andorate Auxiliary Water Connector, Andorate Valves Set

Applicant Smartdata Suzhou Co., Ltd.

K number K191231

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ODC 2019-04-04

CleverLock Guidewire Locking Device and Biopsy Cap

Applicant Olympus Surgical Technologies America

K number K190164

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ODC 2018-07-26

San Antonio Stopcock

Applicant Cook Incorporated

K number K181712

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ODC 2018-03-22

Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter

Applicant Cook Incorporated

K number K173105

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ODC 2017-04-27

Accessory Irrigation Adapter

Applicant Wilson-Cook Medical, Inc.

K number K162142

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ODC 2016-05-19

SmartStart Air/Water and Suction Valves

Applicant Endochoice, Inc.

K number K160403

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ODC 2012-05-18

CONCENTRIC BALLOON GOOGLE

Applicant United States Endoscopy Group, Inc.

K number K112698

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ODC 2012-02-06

NAVIAID ICVI-F,S,B,R DEVICE

Applicant Smart Medical Systems , Ltd.

K number K112106

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ODC 2011-10-28

SUMO ACCESS AND TISSUE RESECTION SYSTEM

Applicant Apollo Endosurgery, Inc.

K number K103155

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ODC 2011-08-09

NAVIAID(TM) BGC DEVICE

Applicant Smart Medical Systems , Ltd.

K number K111760

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ODC 2011-06-17

NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE

Applicant Smart Medical Systems , Ltd.

K number K110291

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ODC 2011-06-10

DEFENDO Y-OPSY IRRIGATOR

Applicant Byrne Medical Incorporated

K number K110088

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ODC 2010-11-08

DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305

Applicant Byrne Medical, Inc.

K number K102581

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ODC 2010-11-04

DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304

Applicant Byrne Medical, Inc.

K number K102409

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ODC 2010-05-17

CLEARJET

Applicant Easyglide , Ltd.

K number K101094

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ODC 2010-02-16

SCOPE INTRODUCER MODEL 7400

Applicant N.M. Beale Co., Inc.

K number K093329

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ODC 2009-07-02

DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)

Applicant Byrne Medical, Inc.

K number K090851

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ODC 2008-05-06

SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100

Applicant Max Endoscopy, Inc.

K number K080764

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ODC 2008-03-10

ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432

Applicant Ethicon Endo-Surgery, Inc.

K number K073484

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ODC 2008-03-05

ANCHORAGE ACCESS KIT

Applicant Epitek, Inc.

K number K073507

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ODC 2003-03-24

LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT

Applicant Lsi Solutions

K number K024301

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ODC 2001-03-27

RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

Applicant Boston Scientific Corp

K number K010610

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ODC 1997-02-19

BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)

Applicant Bard Medical Div.

K number K970110

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ODC 1992-03-18

SURESEAL ENDOSCOPIC VALVE

Applicant Applied Urology, Inc.

K number K920030

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ODC 1992-02-18

ANGEION ENDOSCOPIC VALVE SEAL

Applicant Angeion Corp.

K number K915719

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ODC 1989-04-17

MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES

Applicant Circon Acmi

K number K884097

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ODC 1986-09-11

PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR

Applicant Penn Medical Devices, Inc.

K number K862107

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ODC 1980-05-08

M.R. ASSOC. WASHING TUBE/MEASURING TUBE

Applicant Mr Associates, Inc.

K number K800962

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