Endoscopic Irrigation/Suction System
FDA product code OCX · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
93510(k) clearances
0PMA approvals
18recalls
Manufacturers
- Erbe USA, Inc. 6
- Ga Health Company Limited 6
- Byrne Medical, Inc. 5
- Endochoice, Inc. 4
- United States Endoscopy Group, Inc. 4
- Zhejiang Chuangxiang Medical Technology Co., Ltd. 3
- KARL STORZ Endoscopy-America, Inc. 3
- Hobbs Medical, Inc. 3
- Smartdata Suzhou Co., Ltd. 3
- Olympus Medical Systems Corp. 3
- Biotex, Inc. 2
- Medivators, Inc. 2
- Cipher Surgical, Ltd. 2
- Northgate Technologies, Inc. 2
- Jetprep, Ltd. 2
- Tri-Med Specialties, Inc. 2
- Boston Scientific Corporation 2
- Endovations 2
- Partnership Medical Limited 2
- Finemedix Co., Ltd. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251986 | Auxiliary Water Tube MAJ-855OCX · Traditional | Olympus Medical Systems Corporation | 09/26/2025SE |
| K251997 | Single-Use Biopsy Valve (MAJ-1555)OCX · Traditional | Olympus Medical Systems Corporation | 09/25/2025SE |
| K242586 | ArgoCap (200.52)OCX · Traditional | Ovesco Endoscopy AG | 05/22/2025SE |
| K241704 | Endoscopic Water PumpOCX · Traditional | Hangzhou AGS MedTech Co., Ltd. | 03/20/2025SE |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902)OCX · Traditional | Olympus Medical Systems Corporation | 10/07/2024SE |
| K241874 | Aspiration Catheter (2189)OCX · Traditional | Hobbs Medical, Inc. | 09/24/2024SE |
| K242134 | ClearCap Distal AttachmentOCX · Special | Finemedix Co., Ltd. | 08/20/2024SE |
| K233442 | troCarWash SystemOCX · Traditional | Biotex, Inc. | 05/21/2024SE |
| K230773 | Endoscopy Irrigation TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 11/21/2023SE |
| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/08/2023SE |
| K231418 | ENDOGATOR Hybrid Irrigation TubingOCX · Traditional | Medivators | 08/14/2023SE |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingOCX · Traditional | Ga Health Company Limited | 08/01/2023SE |
| K230932 | ANDORATE® Valve KitOCX · Traditional | Ga Health Company Limited | 07/07/2023SE |
| K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A)OCX · Traditional | Saneso, Inc. | 02/27/2023SE |
| K222695 | troCarWash SystemOCX · Traditional | Biotex, Inc. | 02/17/2023SE |
| K223171 | AquaPulse® Irrigation TubingOCX · Special | Ga Health Company Limited | 11/10/2022SE |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle TubingOCX · Traditional | Diversatek Healthcare | 11/08/2022SE |
| K221310 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source TubingOCX · Traditional | Changzhou Endoclean Medical Device Co., Ltd. | 10/07/2022SE |
| K220785 | Clean Connecting TubeOCX · Traditional | Yangzhou Fartley Medical Instrument Technology… | 09/27/2022SE |
| K221824 | OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear…OCX · Special | Cipher Surgical Limited | 08/19/2022SE |
| K221177 | Erbe's Tubing/Cap SetsOCX · Traditional | Erbe USA, Inc. | 08/11/2022SE |
| K210618 | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation…OCX · Traditional | Chongqing Jinshan Science & Technology Co., Ltd. | 10/20/2021SE |
| K203350 | ENDOtubeOCX · Traditional | Nissha Medical Technologies Sas | 09/29/2021SE |
| K202616 | ClearCap Distal AttachmentOCX · Traditional | Finemedix Co., Ltd. | 02/19/2021SE |
| K202560 | AquaPulse Irrigation TubingOCX · Traditional | Ga Health Company Limited | 12/10/2020SE |
| K200479 | AquaPulse Auxiliary Water ConnectorOCX · Traditional | Ga Health Company Limited | 05/15/2020SE |
| K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer ConnectorOCX · Traditional | Ga Health Company Limited | 04/14/2020SE |
| K193250 | Irrigation Tubing with CO2 or AirOCX · Traditional | Keymed (Medical and Industrial Equipment) , Ltd. | 04/06/2020SE |
| K193036 | C2 CryoBalloon EndoGripOCX · Special | Pentax Medical, A Division of Pentax of America… | 11/22/2019SE |
| K191366 | Vacutore Air/Water Bottle TubingOCX · Traditional | Smartdata Suzhou Co., Ltd. | 09/06/2019SE |
| K181457 | EndoStream(TM)OCX · Traditional | Partnership Medical Limited | 07/11/2019SE |
| K181418 | ScopeFlow Pure(TM)OCX · Traditional | Partnership Medical Limited | 07/11/2019SE |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorOCX · Special | Erbe USA, Inc. | 06/27/2019SE |
| K190469 | ERBEFLO 2 Disposable Tubing SystemOCX · Traditional | Erbe USA, Inc. | 05/23/2019SE |
| K182998 | Andorate Auxiliary Water ConnectorOCX · Traditional | Smartdata Suzhou Co., Ltd. | 04/17/2019SE |
| K182319 | Glo-Tip Spray CatheterOCX · Traditional | Wilson-Cook Medical, Inc. | 02/01/2019SE |
| K182444 | ERBEFLO Olympus Scope Port ConnectorOCX · Traditional | Erbe USA, Inc. | 11/06/2018SE |
| K182275 | Seal Single Use Biopsy ValveOCX · Special | Boston Scientific Corporation | 09/13/2018SE |
| K181509 | Endorate Valve SetsOCX · Traditional | Smartdata Suzhou Co., Ltd. | 07/06/2018SE |
| K173758 | Disposable Biopsy ValveOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 05/14/2018SE |
| K171637 | OpClear SystemOCX · Traditional | Cipher Surgical, Ltd. | 02/26/2018SE |
| K161167 | Seal Single-Use Biopsy ValveOCX · Special | Endochoice, Inc. | 05/26/2016SE |
| K152278 | ENDOFLOW II - Irrigation, Warming and Suction SystemOCX · Traditional | Promepla Sam | 02/09/2016SE |
| K152140 | Boa Endoscopic ValveOCX · Traditional | C2 Therapeutics, Inc. | 10/13/2015SE |
| K142068 | Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating…OCX · Traditional | Medovations, Inc. | 03/10/2015SE |
| K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port…OCX · Special | Erbe USA, Inc. | 12/18/2014SE |
| K140753 | Endo Smart Bottle, Rinse and Insufflation SystemOCX · Special | Medivators | 07/15/2014SE |
| K140315 | US Endoscopy Distal Attachment CapOCX · Traditional | United States Endoscopy Group, Inc. | 04/04/2014SE |
| K133734 | Seal Single-Use Biopsy ValveOCX · Special | Endochoice, Inc. | 03/19/2014SE |
| K140405 | Torrent Irrigation SystemOCX · Special | United States Endoscopy Group, Inc. | 03/12/2014SE |
| K131426 | Medline Biopsy ValveOCX · Traditional | Medline Industries, Inc. | 02/21/2014SE |
| K132776 | Seal Biopsy Valve - ReusableOCX · Traditional | Endochoice, Inc. | 12/20/2013SE |
| K122417 | Scopevalet Disposable Biopsy ValveOCX · Traditional | The Ruhof Corp. | 05/17/2013SE |
| K130909 | Gateway Advanage Y-AdapterOCX · Traditional | Boston Scientific Corp | 05/16/2013SE |
| K122740 | Jetprep Flushing Device OL-103037, Jetprep Flushing Device OL-133037, Jetprep Flushing…OCX · Special | Jetprep, Ltd. | 12/10/2012SE |
| K112318 | Clearpath 24OCX · Traditional | Promedic, Inc. | 06/29/2012SE |
| K113119 | Endogator Advantage Irrigation PumpOCX · Traditional | Byrne Medical, Inc. | 04/27/2012SE |
| K111274 | Jetprep Flushing Device OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 /…OCX · Traditional | Jetprep, Ltd. | 04/04/2012SE |
| K111821 | Biopsy ValveOCX · Traditional | Endochoice, Inc. | 07/28/2011SE |
| K103239 | Irrigation SystemOCX · Traditional | United States Endoscopy Group, Inc. | 12/30/2010SE |
| K103235 | Erbeflo 2 Disposable Tubing SystemOCX · Traditional | Erbe USA, Inc. | 12/23/2010SE |
| K102855 | Universal Irrigation Solution HybridOCX · Traditional | Byrne Medical, Inc. | 11/19/2010SE |
| K092461 | Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140OCX · Traditional | United States Endoscopy Group, Inc. | 11/05/2009SE |
| K060962 | Endogator Endoscopy Irrigation Pump, Model EGP-100OCX · Traditional | Byrne Medical, Inc. | 04/19/2006SE |
| K031457 | Endomat LC Pump, Model 20 3303 20OCX · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/28/2004SE |
| K033695 | Irrigation Channel Tubing, Model 100135OCX · Traditional | Byrne Medical, Inc. | 12/23/2003SE |
| K031773 | Endo Gator SystemOCX · Traditional | Byrne Medical, Inc. | 06/24/2003SE |
| K030765 | Hobbs Mistifier Spray CatheterOCX · Traditional | Hobbs Medical, Inc. | 06/09/2003SE |
| K021776 | Ksea Quadro SwitchOCX · Traditional | Karl Storz Endoscopy | 08/15/2002SE |
| K020614 | Irrigating CannulaOCX · Traditional | Ca Guard, Ltd. | 05/24/2002SE |
| K993778 | Hydrotower Management System, Model 4-750-00OCX · Special | Northgate Technologies, Inc. | 01/06/2000SE |
| K992535 | Endius Suction/Irrigation InstrumentOCX · Traditional | Endius, Inc. | 09/01/1999SE |
| K971125 | Endo Smartcap (100501)OCX · Traditional | Endo Smart Cap Co. | 05/23/1997SE |
| K970764 | Comeg Endoscopy Resectoscope AccessoriesOCX · Traditional | Comeg Endoscopy | 04/22/1997SE |
| K964196 | Continuous Flow System, CFS-1 Pump System (4-700-00)OCX · Traditional | Northgate Technologies, Inc. | 12/23/1996SE |
| K953655 | J-Vac Suction Reservoirs & J-Vac Blake Silicone DrainsOCX · Traditional | Johnson & Johnson Medical, Inc. | 10/13/1995SE |
| K942918 | Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional | Tri-Med Specialties, Inc. | 02/28/1995SE |
| K934170 | Endomedix Y-AdapterOCX · Traditional | Endomedix | 01/11/1994SE |
| K931201 | Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional | Tri-Med Specialties, Inc. | 09/28/1993SE |
| K905102 | Bard(R) Syringe Assist IrrigationOCX · Traditional | C.R. Bard, Inc. | 04/09/1991SE |
| K903834 | N. M. Beale Company Vu-Thru Water BottleOCX · Traditional | N.M. Beale Co., Inc. | 09/24/1990SE |
| K892426 | No. 86500 - Endoscopic Jet WasherOCX · Traditional | Superior Healthcare Group, Inc. | 06/22/1989SE |
| K891339 | Irri-Flo Irrigation Delivery SystemOCX · Traditional | Surgitek | 06/02/1989SE |
| K883173 | Model 27084 Uromat for Urological IrrigationOCX · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/25/1988SE |
| K875264 | Washing CatheterOCX · Traditional | Endovations | 03/29/1988SE |
| K862058 | Rapid Endoscopic Lavage SystemOCX · Traditional | Endovations | 08/11/1986SE |
| K844550 | Hobbs Medical/Jayco Aspiration CatheterOCX · Traditional | Hobbs Medical, Inc. | 01/03/1985SE |
| K844691 | Endoscopic Aspiration Catheter SetOCX · Traditional | Jayco Pharmaceuticals | 01/02/1985SE |
| K833331 | Aspiration & Irrigation CatheterOCX · Traditional | Microvasive | 11/14/1983SE |
| K832009 | Model #27224P Continuous Flow PumpOCX · Traditional | KARL STORZ Endoscopy-America, Inc. | 07/18/1983SE |
| K822061 | Lavaging CathetersOCX · Traditional | American Endoscopy, Inc. | 07/20/1982SE |
| K810506 | Propper Sigmoidoscope Suction InstrumentOCX · Traditional | Propper Mfg. Co., Inc. | 04/07/1981SE |
| K760451 | Air Water Source (Acmi Model 710)OCX · Traditional | American Cystocope Makers, Inc. | 08/30/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2064-2026 Class II | ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment… | Erbe Medical, LLC | 03/31/2026Open, Classified |
| Z-2063-2026 Class II | ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO…Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment… | Erbe Medical, LLC | 03/31/2026Open, Classified |
| Z-0011-2023 Class II | Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy…Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0010-2023 Class II | Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy…Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0649-2021 Class II | ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-0648-2021 Class II | ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-0647-2021 Class II | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-0646-2021 Class II | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-0645-2021 Class II | Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-0644-2021 Class II | Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-0643-2021 Class II | Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-0642-2021 Class II | STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-0641-2021 Class II | STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction)…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-0640-2021 Class II | STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxilia…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-0639-2021 Class II | STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R…Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Ga Health Company Limited | 11/03/2020Terminated |
| Z-1943-2015 Class II | Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy…The company has received reports of structural non conformance at the connection between the valve body and… | US Endoscopy Group Inc | 02/17/2015Terminated |
| Z-1010-2015 Class II | Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic…Potential for failure of the pouch packaging seal at high altitudes. | Baxter Healthcare Corp. | 01/14/2015Terminated |
| Z-1099-2013 Class II | Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and…The firm was notified by their customers that there was a water leakage from the white tubing connector. | US Endoscopy Group Inc | 03/07/2013Terminated |