Atlas FDA

ODC

72 FDA 510(k) clearances · Product code

110 daysmedian time to decision
269 days90th percentile
72clearances measured

FDA profile

Official device name
Endoscope Channel Accessory
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To give the endoscope channel additional or improved functionality.
Adverse events (MAUDE)
2021: 52 · 2022: 37 · 2023: 43 · 2024: 100 · 2025: 91 · 2026: 205
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
DYNE PORT (K252933)Dyne Medical Group, Inc.2026-06-12
Biopsy Port Adapter (K250145)Endosound, Inc.2025-10-17
Orca Air/Water and Suction Valves (K252910)Boston Scientific2025-10-09
Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (K250949)Olympus Medical Systems Corporation2025-07-16
Disposable Endoscopy Valve Set (K250732)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2025-06-20
Luer-Split MAJ-2092 (K241842)Olympus Medical Systems Corporation2025-03-19
Defendo Fujifilm 700 Single Use Cleaning Adapter (K250140)Steris Corparation2025-02-20
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) (K243075)STERIS Corporation2024-11-08
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (K242742)STERIS Corporation2024-10-11
Disposable Endoscope Valves Set (AF series) (K241285)Alton (Shanghai) Medical Instruments Co., Ltd.2024-10-01
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 (K232067)Medivators (A Subsidiary of Steris Corporation)2024-03-22
Endorail (K232327)Endostart S.R.L.2024-03-15
Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector (K232004)Medivators (A Subsidiary of Steris Corporation)2024-03-06
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (K240352)STERIS Corporation2024-03-06
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (K240098)STERIS Corporation2024-02-09
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 (K232329)Medivators (A Subsidiary of Steris Corporation)2023-12-21
PENTAX Medical Gas/Water Feeding Valve OE-B14 (K232249)Pentax of America, Inc.2023-12-01
Disposable Endoscope Valves System (K232244)Changzhou Endoclean Medical Device Co., Ltd.2023-11-29
Disposable Endoscope Valves Kit (K222499)Shanghai SeeGen Photoelectric Technology Co., Ltd.2023-11-22
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) (K232951)Steris2023-10-20
ANDORATE® Valve Kit (K232118)Ga Health Company Limited2023-10-16
Disposable Endoscope Valve Sets (K220884)Sml Med-Tech Solutions Limited2023-01-17
Pentax Medical Valve Set (K222980)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2022-11-21
Disposable Endoscope Valves System (K221331)Changzhou Endoclean Medical Device Co., Ltd.2022-09-08
Disposable Endoscopy Adapter Set (K220210)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2022-06-17
FROG Forceps Valve (VAL1-F1-100) (K221264)Fujifilm Medwork GmbH2022-06-01
SnapLoc Wire Lock (K213483)Wilson Cook Medical2022-04-26
Guidewire Locking Device (K220247)Micro-Tech (Nanjing) Co., Ltd.2022-03-29
Wellead Endoscopic Seal (K211814)Well Lead Medical Co., Ltd.2022-01-14
andorate Suction Valve, andorate Air/Water Valve (K213095)Ga Health Company Limited2022-01-12
JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve (K210625)Fujifilm Medwork GmbH2021-09-10
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor (K210342)STERIS Corporation2021-09-03
AutoCap RX (K210353)Boston Scientific Corporation2021-05-06
BioGuard EUS Air/Water and Suction Valves (K202104)STERIS Corporation2021-01-14
BioGuard Air/Water and Suction Valves (K203630)Steris Corporations2021-01-08
Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B (K200769)Wilson Instruments (Sha) Co., Ltd.2021-01-06
Locking device (K202237)Hangzhou AGS MedTech Co., Ltd.2020-12-23
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve (K200495)Ga Health Company Limited2020-06-24
Andorate Biopsy Valve, Andorate Biopsy Irrigator (K200481)Ga Health Company Limited2020-06-18
Single Use Endoscope Valves Set (K192048)Anrei Medical (Hangzhou) Co., Ltd.2020-05-14
Disposable Valve Sets (K192258)Zhejiang Chuangxiang Medical Technology Co., Ltd.2019-12-30
Bio Guard Air/Water & Suction Valves (K192059)United States Endoscopy Group, Inc.2019-09-17
Andorate Auxiliary Water Connector, Andorate Valves Set (K191231)Smartdata Suzhou Co., Ltd.2019-06-07
CleverLock Guidewire Locking Device and Biopsy Cap (K190164)Olympus Surgical Technologies America2019-04-04
San Antonio Stopcock (K181712)Cook Incorporated2018-07-26
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter (K173105)Cook Incorporated2018-03-22
Accessory Irrigation Adapter (K162142)Wilson-Cook Medical, Inc.2017-04-27
SmartStart Air/Water and Suction Valves (K160403)Endochoice, Inc.2016-05-19
Disposable Endoscope Valves Set A (K151714)Wilson Instruments (Shanghai) Company Limited2015-12-03
BioGuard Air/Water Valve, BioGuard Suction Valve (K151345)United States Endoscopy Group, Inc.2015-08-25
CONCENTRIC BALLOON GOOGLE (K112698)United States Endoscopy Group, Inc.2012-05-18
NAVIAID ICVI-F,S,B,R DEVICE (K112106)Smart Medical Systems , Ltd.2012-02-06
SUMO ACCESS AND TISSUE RESECTION SYSTEM (K103155)Apollo Endosurgery, Inc.2011-10-28
NAVIAID(TM) BGC DEVICE (K111760)Smart Medical Systems , Ltd.2011-08-09
NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE (K110291)Smart Medical Systems , Ltd.2011-06-17
DEFENDO Y-OPSY IRRIGATOR (K110088)Byrne Medical Incorporated2011-06-10
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 (K102581)Byrne Medical, Inc.2010-11-08
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 (K102409)Byrne Medical, Inc.2010-11-04
CLEARJET (K101094)Easyglide , Ltd.2010-05-17
SCOPE INTRODUCER MODEL 7400 (K093329)N.M. Beale Co., Inc.2010-02-16
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) (K090851)Byrne Medical, Inc.2009-07-02
SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 (K080764)Max Endoscopy, Inc.2008-05-06
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 (K073484)Ethicon Endo-Surgery, Inc.2008-03-10
ANCHORAGE ACCESS KIT (K073507)Epitek, Inc.2008-03-05
LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT (K024301)Lsi Solutions2003-03-24
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 (K010610)Boston Scientific Corp2001-03-27
BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) (K970110)Bard Medical Div.1997-02-19
SURESEAL ENDOSCOPIC VALVE (K920030)Applied Urology, Inc.1992-03-18
ANGEION ENDOSCOPIC VALVE SEAL (K915719)Angeion Corp.1992-02-18
MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES (K884097)Circon Acmi1989-04-17
PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR (K862107)Penn Medical Devices, Inc.1986-09-11
M.R. ASSOC. WASHING TUBE/MEASURING TUBE (K800962)Mr Associates, Inc.1980-05-08

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