Atlas FDA

OCX

93 FDA 510(k) clearances · Product code

88 daysmedian time to decision
269 days90th percentile
93clearances measured

FDA profile

Official device name
Endoscopic Irrigation/Suction System
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Adverse events (MAUDE)
2019: 41 · 2022: 18 · 2023: 46 · 2024: 21 · 2025: 33 · 2026: 30
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
AUXILIARY WATER TUBE MAJ-855 (K251986)Olympus Medical Systems Corporation2025-09-26
Single-Use Biopsy Valve (MAJ-1555) (K251997)Olympus Medical Systems Corporation2025-09-25
ArgoCap (200.52) (K242586)Ovesco Endoscopy AG2025-05-22
Endoscopic Water Pump (K241704)Hangzhou AGS MedTech Co., Ltd.2025-03-20
Water Container (MAJ-901); Water Container (MAJ-902) (K242357)Olympus Medical Systems Corporation2024-10-07
Aspiration Catheter (2189) (K241874)Hobbs Medical, Inc.2024-09-24
ClearCap Distal Attachment (K242134)Finemedix Co., Ltd.2024-08-20
troCarWash™ System (K233442)Biotex, Inc.2024-05-21
Endoscopy Irrigation Tubing (K230773)Zhejiang Chuangxiang Medical Technology Co., Ltd.2023-11-21
Air/Water Bottle Tubing, CO2 Source Tubing (K231471)Zhejiang Chuangxiang Medical Technology Co., Ltd.2023-09-08
ENDOGATOR™ Hybrid Irrigation Tubing (K231418)Medivators2023-08-14
Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing (K231602)Ga Health Company Limited2023-08-01
ANDORATE® Valve Kit (K230932)Ga Health Company Limited2023-07-07
Saneso Lens Wash Bottle Assembly (SAN-LWB-A) (K222173)Saneso, Inc.2023-02-27
troCarWash™ System (K222695)Biotex, Inc.2023-02-17
AquaPulse® Irrigation Tubing (K223171)Ga Health Company Limited2022-11-10
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing (K222734)Diversatek Healthcare2022-11-08
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing (K221310)Changzhou Endoclean Medical Device Co., Ltd.2022-10-07
Clean Connecting Tube (K220785)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2022-09-27
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 (K221824)Cipher Surgical Limited2022-08-19
Erbe's Tubing/Cap Sets (K221177)Erbe USA, Inc.2022-08-11
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series (K210618)Chongqing Jinshan Science & Technology Co., Ltd.2021-10-20
ENDOtube (K203350)Nissha Medical Technologies Sas2021-09-29
ClearCap Distal Attachment (K202616)Finemedix Co., Ltd.2021-02-19
AquaPulse Irrigation Tubing (K202560)Ga Health Company Limited2020-12-10
AquaPulse Auxiliary Water Connector (K200479)Ga Health Company Limited2020-05-15
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector (K200388)Ga Health Company Limited2020-04-14
Irrigation Tubing with CO2 or Air (K193250)Keymed (Medical and Industrial Equipment) , Ltd.2020-04-06
C2 CryoBalloon EndoGrip (K193036)Pentax Medical, A Division of Pentax of America, Inc.2019-11-22
Vacutore Air/Water Bottle Tubing (K191366)Smartdata Suzhou Co., Ltd.2019-09-06
ScopeFlow Pure(TM) (K181418)Partnership Medical Limited2019-07-11
EndoStream(TM) (K181457)Partnership Medical Limited2019-07-11
ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector (K191438)Erbe USA, Inc.2019-06-27
ERBEFLO 2 Disposable Tubing System (K190469)Erbe USA, Inc.2019-05-23
Andorate Auxiliary Water Connector (K182998)Smartdata Suzhou Co., Ltd.2019-04-17
Glo-Tip Spray Catheter (K182319)Wilson-Cook Medical, Inc.2019-02-01
ERBEFLO Olympus Scope Port Connector (K182444)Erbe USA, Inc.2018-11-06
Seal Single Use Biopsy Valve (K182275)Boston Scientific Corporation2018-09-13
Endorate Valve Sets (K181509)Smartdata Suzhou Co., Ltd.2018-07-06
Disposable Biopsy Valve (K173758)Zhejiang Chuangxiang Medical Technology Co., Ltd.2018-05-14
OpClear System (K171637)Cipher Surgical, Ltd.2018-02-26
Seal Single-Use Biopsy Valve (K161167)Endochoice, Inc.2016-05-26
ENDOFLOW II - Irrigation, Warming and Suction System (K152278)Promepla Sam2016-02-09
Boa Endoscopic Valve (K152140)C2 Therapeutics, Inc.2015-10-13
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE (K142068)Medovations, Inc.2015-03-10
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector (K143186)Erbe USA, Inc.2014-12-18
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM (K140753)Medivators2014-07-15
US ENDOSCOPY DISTAL ATTACHMENT CAP (K140315)United States Endoscopy Group, Inc.2014-04-04
SEAL SINGLE-USE BIOPSY VALVE (K133734)Endochoice, Inc.2014-03-19
TORRENT IRRIGATION SYSTEM (K140405)United States Endoscopy Group, Inc.2014-03-12
MEDLINE BIOPSY VALVE (K131426)Medline Industries, Inc.2014-02-21
SEAL BIOPSY VALVE - REUSABLE (K132776)Endochoice, Inc.2013-12-20
SCOPEVALET DISPOSABLE BIOPSY VALVE (K122417)The Ruhof Corp.2013-05-17
GATEWAY ADVANAGE Y-ADAPTER (K130909)Boston Scientific Corp2013-05-16
JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN (K122740)Jetprep, Ltd.2012-12-10
CLEARPATH 24 (K112318)Promedic, Inc.2012-06-29
ENDOGATOR ADVANTAGE IRRIGATION PUMP (K113119)Byrne Medical, Inc.2012-04-27
JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 (K111274)Jetprep, Ltd.2012-04-04
BIOPSY VALVE (K111821)Endochoice, Inc.2011-07-28
IRRIGATION SYSTEM (K103239)United States Endoscopy Group, Inc.2010-12-30
ERBEFLO 2 DISPOSABLE TUBING SYSTEM (K103235)Erbe USA, Inc.2010-12-23
UNIVERSAL IRRIGATION SOLUTION HYBRID (K102855)Byrne Medical, Inc.2010-11-19
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 (K092461)United States Endoscopy Group, Inc.2009-11-05
ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 (K060962)Byrne Medical, Inc.2006-04-19
ENDOMAT LC PUMP, MODEL 20 3303 20 (K031457)KARL STORZ Endoscopy-America, Inc.2004-04-28
IRRIGATION CHANNEL TUBING, MODEL 100135 (K033695)Byrne Medical, Inc.2003-12-23
ENDO GATOR SYSTEM (K031773)Byrne Medical, Inc.2003-06-24
HOBBS MISTIFIER SPRAY CATHETER (K030765)Hobbs Medical, Inc.2003-06-09
KSEA QUADRO SWITCH (K021776)Karl Storz Endoscopy2002-08-15
IRRIGATING CANNULA (K020614)Ca Guard, Ltd.2002-05-24
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 (K993778)Northgate Technologies, Inc.2000-01-06
ENDIUS SUCTION/IRRIGATION INSTRUMENT (K992535)Endius, Inc.1999-09-01
ENDO SMARTCAP (100501) (K971125)Endo Smart Cap Co.1997-05-23
COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES (K970764)Comeg Endoscopy1997-04-22
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) (K964196)Northgate Technologies, Inc.1996-12-23
J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS (K953655)Johnson & Johnson Medical, Inc.1995-10-13
TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (K942918)Tri-Med Specialties, Inc.1995-02-28
ENDOMEDIX Y-ADAPTER (K934170)Endomedix1994-01-11
TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (K931201)Tri-Med Specialties, Inc.1993-09-28
BARD(R) SYRINGE ASSIST IRRIGATION (K905102)C.R. Bard, Inc.1991-04-09
N. M. BEALE COMPANY VU-THRU WATER BOTTLE (K903834)N.M. Beale Co., Inc.1990-09-24
NO. 86500 - ENDOSCOPIC JET WASHER (K892426)Superior Healthcare Group, Inc.1989-06-22
IRRI-FLO IRRIGATION DELIVERY SYSTEM (K891339)Surgitek1989-06-02
MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION (K883173)KARL STORZ Endoscopy-America, Inc.1988-10-25
WASHING CATHETER (K875264)Endovations1988-03-29
RAPID ENDOSCOPIC LAVAGE SYSTEM (K862058)Endovations1986-08-11
HOBBS MEDICAL/JAYCO ASPIRATION CATHETER (K844550)Hobbs Medical, Inc.1985-01-03
ENDOSCOPIC ASPIRATION CATHETER SET (K844691)Jayco Pharmaceuticals1985-01-02
ASPIRATION & IRRIGATION CATHETER (K833331)Microvasive1983-11-14
MODEL #27224P CONTINUOUS FLOW PUMP (K832009)KARL STORZ Endoscopy-America, Inc.1983-07-18
LAVAGING CATHETERS (K822061)American Endoscopy, Inc.1982-07-20
PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT (K810506)Propper Mfg. Co., Inc.1981-04-07
AIR WATER SOURCE (ACMI MODEL 710) (K760451)American Cystocope Makers, Inc.1976-08-30

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