Endoscopic Irrigation/Suction System

FDA product code OCX · 85 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: 1976-08-30 – 2025-09-26

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

OCX 2025-09-26

AUXILIARY WATER TUBE MAJ-855

Applicant Olympus Medical Systems Corporation

K number K251986

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OCX 2025-09-25

Single-Use Biopsy Valve (MAJ-1555)

Applicant Olympus Medical Systems Corporation

K number K251997

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OCX 2025-05-22

ArgoCap (200.52)

Applicant Ovesco Endoscopy AG

K number K242586

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OCX 2025-03-20

Endoscopic Water Pump

Applicant Hangzhou AGS MedTech Co., Ltd.

K number K241704

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OCX 2024-10-07

Water Container (MAJ-901); Water Container (MAJ-902)

Applicant Olympus Medical Systems Corporation

K number K242357

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OCX 2024-09-24

Aspiration Catheter (2189)

Applicant Hobbs Medical, Inc.

K number K241874

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OCX 2024-08-20

ClearCap Distal Attachment

Applicant Finemedix Co., Ltd.

K number K242134

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OCX 2024-05-21

troCarWash™ System

Applicant Biotex, Inc.

K number K233442

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OCX 2023-11-21

Endoscopy Irrigation Tubing

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K number K230773

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OCX 2023-09-08

Air/Water Bottle Tubing, CO2 Source Tubing

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K number K231471

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OCX 2023-08-14

ENDOGATOR™ Hybrid Irrigation Tubing

Applicant Medivators

K number K231418

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OCX 2023-08-01

Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing

Applicant Ga Health Company Limited

K number K231602

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OCX 2023-07-07

ANDORATE® Valve Kit

Applicant Ga Health Company Limited

K number K230932

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OCX 2023-02-27

Saneso Lens Wash Bottle Assembly (SAN-LWB-A)

Applicant Saneso, Inc.

K number K222173

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OCX 2023-02-17

troCarWash™ System

Applicant Biotex, Inc.

K number K222695

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OCX 2022-11-10

AquaPulse® Irrigation Tubing

Applicant Ga Health Company Limited

K number K223171

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OCX 2022-11-08

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing

Applicant Diversatek Healthcare

K number K222734

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OCX 2022-10-07

Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing

Applicant Changzhou Endoclean Medical Device Co., Ltd.

K number K221310

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OCX 2022-09-27

Clean Connecting Tube

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K number K220785

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OCX 2022-08-19

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

Applicant Cipher Surgical Limited

K number K221824

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OCX 2022-08-11

Erbe's Tubing/Cap Sets

Applicant Erbe USA, Inc.

K number K221177

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OCX 2021-10-20

Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series

Applicant Chongqing Jinshan Science & Technology Co., Ltd.

K number K210618

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OCX 2021-09-29

ENDOtube

Applicant Nissha Medical Technologies Sas

K number K203350

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OCX 2021-02-19

ClearCap Distal Attachment

Applicant Finemedix Co., Ltd.

K number K202616

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OCX 2020-12-10

AquaPulse Irrigation Tubing

Applicant Ga Health Company Limited

K number K202560

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OCX 2020-05-15

AquaPulse Auxiliary Water Connector

Applicant Ga Health Company Limited

K number K200479

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OCX 2020-04-14

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector

Applicant Ga Health Company Limited

K number K200388

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OCX 2020-04-06

Irrigation Tubing with CO2 or Air

Applicant Keymed (Medical and Industrial Equipment) , Ltd.

K number K193250

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OCX 2019-11-22

C2 CryoBalloon EndoGrip

Applicant Pentax Medical, A Division of Pentax of America, Inc.

K number K193036

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OCX 2019-09-06

Vacutore Air/Water Bottle Tubing

Applicant Smartdata Suzhou Co., Ltd.

K number K191366

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OCX 2019-07-11

EndoStream(TM)

Applicant Partnership Medical Limited

K number K181457

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OCX 2019-07-11

ScopeFlow Pure(TM)

Applicant Partnership Medical Limited

K number K181418

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OCX 2019-06-27

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector

Applicant Erbe USA, Inc.

K number K191438

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OCX 2019-05-23

ERBEFLO 2 Disposable Tubing System

Applicant Erbe USA, Inc.

K number K190469

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OCX 2019-04-17

Andorate Auxiliary Water Connector

Applicant Smartdata Suzhou Co., Ltd.

K number K182998

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OCX 2019-02-01

Glo-Tip Spray Catheter

Applicant Wilson-Cook Medical, Inc.

K number K182319

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OCX 2018-11-06

ERBEFLO Olympus Scope Port Connector

Applicant Erbe USA, Inc.

K number K182444

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OCX 2018-09-13

Seal Single Use Biopsy Valve

Applicant Boston Scientific Corporation

K number K182275

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OCX 2018-07-06

Endorate Valve Sets

Applicant Smartdata Suzhou Co., Ltd.

K number K181509

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OCX 2018-05-14

Disposable Biopsy Valve

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K number K173758

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OCX 2018-02-26

OpClear System

Applicant Cipher Surgical, Ltd.

K number K171637

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OCX 2016-05-26

Seal Single-Use Biopsy Valve

Applicant Endochoice, Inc.

K number K161167

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OCX 2016-02-09

ENDOFLOW II - Irrigation, Warming and Suction System

Applicant Promepla Sam

K number K152278

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OCX 2013-12-20

SEAL BIOPSY VALVE - REUSABLE

Applicant Endochoice, Inc.

K number K132776

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OCX 2013-05-17

SCOPEVALET DISPOSABLE BIOPSY VALVE

Applicant The Ruhof Corp.

K number K122417

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OCX 2013-05-16

GATEWAY ADVANAGE Y-ADAPTER

Applicant Boston Scientific Corp

K number K130909

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OCX 2012-12-10

JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN

Applicant Jetprep, Ltd.

K number K122740

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OCX 2012-06-29

CLEARPATH 24

Applicant Promedic, Inc.

K number K112318

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OCX 2012-04-27

ENDOGATOR ADVANTAGE IRRIGATION PUMP

Applicant Byrne Medical, Inc.

K number K113119

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OCX 2012-04-04

JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038

Applicant Jetprep, Ltd.

K number K111274

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OCX 2011-07-28

BIOPSY VALVE

Applicant Endochoice, Inc.

K number K111821

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OCX 2010-12-30

IRRIGATION SYSTEM

Applicant United States Endoscopy Group, Inc.

K number K103239

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OCX 2010-12-23

ERBEFLO 2 DISPOSABLE TUBING SYSTEM

Applicant Erbe USA, Inc.

K number K103235

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OCX 2010-11-19

UNIVERSAL IRRIGATION SOLUTION HYBRID

Applicant Byrne Medical, Inc.

K number K102855

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OCX 2009-11-05

IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140

Applicant United States Endoscopy Group, Inc.

K number K092461

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OCX 2006-04-19

ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100

Applicant Byrne Medical, Inc.

K number K060962

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OCX 2004-04-28

ENDOMAT LC PUMP, MODEL 20 3303 20

Applicant KARL STORZ Endoscopy-America, Inc.

K number K031457

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OCX 2003-12-23

IRRIGATION CHANNEL TUBING, MODEL 100135

Applicant Byrne Medical, Inc.

K number K033695

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OCX 2003-06-24

ENDO GATOR SYSTEM

Applicant Byrne Medical, Inc.

K number K031773

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OCX 2003-06-09

HOBBS MISTIFIER SPRAY CATHETER

Applicant Hobbs Medical, Inc.

K number K030765

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OCX 2002-08-15

KSEA QUADRO SWITCH

Applicant Karl Storz Endoscopy

K number K021776

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OCX 2002-05-24

IRRIGATING CANNULA

Applicant Ca Guard, Ltd.

K number K020614

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OCX 2000-01-06

HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00

Applicant Northgate Technologies, Inc.

K number K993778

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OCX 1999-09-01

ENDIUS SUCTION/IRRIGATION INSTRUMENT

Applicant Endius, Inc.

K number K992535

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OCX 1997-05-23

ENDO SMARTCAP (100501)

Applicant Endo Smart Cap Co.

K number K971125

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OCX 1997-04-22

COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES

Applicant Comeg Endoscopy

K number K970764

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OCX 1996-12-23

CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)

Applicant Northgate Technologies, Inc.

K number K964196

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OCX 1995-10-13

J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS

Applicant Johnson & Johnson Medical, Inc.

K number K953655

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OCX 1995-02-28

TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER

Applicant Tri-Med Specialties, Inc.

K number K942918

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OCX 1994-01-11

ENDOMEDIX Y-ADAPTER

Applicant Endomedix

K number K934170

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OCX 1993-09-28

TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER

Applicant Tri-Med Specialties, Inc.

K number K931201

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OCX 1991-04-09

BARD(R) SYRINGE ASSIST IRRIGATION

Applicant C.R. Bard, Inc.

K number K905102

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OCX 1990-09-24

N. M. BEALE COMPANY VU-THRU WATER BOTTLE

Applicant N.M. Beale Co., Inc.

K number K903834

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OCX 1989-06-22

NO. 86500 - ENDOSCOPIC JET WASHER

Applicant Superior Healthcare Group, Inc.

K number K892426

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OCX 1989-06-02

IRRI-FLO IRRIGATION DELIVERY SYSTEM

Applicant Surgitek

K number K891339

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OCX 1988-10-25

MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION

Applicant KARL STORZ Endoscopy-America, Inc.

K number K883173

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OCX 1988-03-29

WASHING CATHETER

Applicant Endovations

K number K875264

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OCX 1986-08-11

RAPID ENDOSCOPIC LAVAGE SYSTEM

Applicant Endovations

K number K862058

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OCX 1985-01-03

HOBBS MEDICAL/JAYCO ASPIRATION CATHETER

Applicant Hobbs Medical, Inc.

K number K844550

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OCX 1985-01-02

ENDOSCOPIC ASPIRATION CATHETER SET

Applicant Jayco Pharmaceuticals

K number K844691

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OCX 1983-11-14

ASPIRATION & IRRIGATION CATHETER

Applicant Microvasive

K number K833331

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OCX 1983-07-18

MODEL #27224P CONTINUOUS FLOW PUMP

Applicant KARL STORZ Endoscopy-America, Inc.

K number K832009

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OCX 1982-07-20

LAVAGING CATHETERS

Applicant American Endoscopy, Inc.

K number K822061

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OCX 1981-04-07

PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT

Applicant Propper Mfg. Co., Inc.

K number K810506

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OCX 1976-08-30

AIR WATER SOURCE (ACMI MODEL 710)

Applicant American Cystocope Makers, Inc.

K number K760451

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