Product Code: OCX FDA class 2 21 CFR 876.1500

Endoscopic Irrigation/Suction System

Gastroenterology, Urology

The Endoscopic Irrigation/Suction System (product code OCX) is a gastroenterology and urology device used to supply sterile water or other solutions to endoscopes and to apply suction during endoscopic procedures, maintaining a clear operative field and flushing debris or blood from the working area. These functions are essential for visibility and safety during endoscopy. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: OCX
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 93 510(k) clearances via K numbers.

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