FDA 510(k) Applications for Medical Device Product Code "OCX"
(Endoscopic Irrigation/Suction System)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K222695 | Biotex Inc. | troCarWashÖ System | 02/17/2023 |
| K130909 | BOSTON SCIENTIFIC CORP. | GATEWAY ADVANAGE Y-ADAPTER | 05/16/2013 |
| K182275 | Boston Scientific Corporation | Seal Single Use Biopsy Valve | 09/13/2018 |
| K031773 | BYRNE MEDICAL, INC. | ENDO GATOR SYSTEM | 06/24/2003 |
| K113119 | BYRNE MEDICAL, INC. | ENDOGATOR ADVANTAGE IRRIGATION PUMP | 04/27/2012 |
| K060962 | BYRNE MEDICAL, INC. | ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 | 04/19/2006 |
| K033695 | BYRNE MEDICAL, INC. | IRRIGATION CHANNEL TUBING, MODEL 100135 | 12/23/2003 |
| K102855 | BYRNE MEDICAL, INC. | UNIVERSAL IRRIGATION SOLUTION HYBRID | 11/19/2010 |
| K152140 | C2 THERAPEUTICS, INC. | Boa Endoscopic Valve | 10/13/2015 |
| K020614 | CA GUARD, LTD. | IRRIGATING CANNULA | 05/24/2002 |
| K221310 | Changzhou Endoclean Medical Device Co., Ltd. | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | 10/07/2022 |
| K210618 | Chongqing Jinshan Science & Technology Co., Ltd. | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series | 10/20/2021 |
| K221824 | Cipher Surgical Limited | 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-05-00-30 | 08/19/2022 |
| K171637 | Cipher Surgical Ltd | OpClear System | 02/26/2018 |
| K970764 | COMEG ENDOSCOPY | COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES | 04/22/1997 |
| K222734 | Diversatek Healthcare | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing | 11/08/2022 |
| K992535 | ENDIUS, INC. | ENDIUS SUCTION/IRRIGATION INSTRUMENT | 09/01/1999 |
| K971125 | ENDO SMART CAP CO. | ENDO SMARTCAP (100501) | 05/23/1997 |
| K111821 | ENDOCHOICE, INC. | BIOPSY VALVE | 07/28/2011 |
| K132776 | ENDOCHOICE, INC. | SEAL BIOPSY VALVE - REUSABLE | 12/20/2013 |
| K133734 | ENDOCHOICE, INC. | SEAL SINGLE-USE BIOPSY VALVE | 03/19/2014 |
| K161167 | ENDOCHOICE, INC. | Seal Single-Use Biopsy Valve | 05/26/2016 |
| K143186 | ERBE USA, INC. | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector | 12/18/2014 |
| K221177 | Erbe USA, Inc. | Erbe's Tubing/Cap Sets | 08/11/2022 |
| K190469 | Erbe USA, Inc. | ERBEFLO 2 Disposable Tubing System | 05/23/2019 |
| K103235 | ERBE USA, INC. | ERBEFLO 2 DISPOSABLE TUBING SYSTEM | 12/23/2010 |
| K191438 | Erbe USA, Inc. | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector | 06/27/2019 |
| K182444 | Erbe USA, Inc. | ERBEFLO Olympus Scope Port Connector | 11/06/2018 |
| K202616 | Finemedix Co., Ltd. | ClearCap Distal Attachment | 02/19/2021 |
| K230932 | GA Health Company Limited | ANDORATE« Valve Kit | 07/07/2023 |
| K200479 | GA Health Company Limited | AquaPulse Auxiliary Water Connector | 05/15/2020 |
| K202560 | GA Health Company Limited | AquaPulse Irrigation Tubing | 12/10/2020 |
| K223171 | GA Health Company Limited | AquaPulse« Irrigation Tubing | 11/10/2022 |
| K231602 | GA Health Company Limited | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | 08/01/2023 |
| K200388 | GA Health Company Limited | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector | 04/14/2020 |
| K030765 | HOBBS MEDICAL, INC. | HOBBS MISTIFIER SPRAY CATHETER | 06/09/2003 |
| K111274 | JETPREP, LTD. | JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 | 04/04/2012 |
| K122740 | JETPREP, LTD. | JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN | 12/10/2012 |
| K021776 | KARL STORZ ENDOSCOPY | KSEA QUADRO SWITCH | 08/15/2002 |
| K031457 | KARL STORZ ENDOSCOPY-AMERICA, INC. | ENDOMAT LC PUMP, MODEL 20 3303 20 | 04/28/2004 |
| K193250 | KeyMed (Medical and Industrial Equipment) Ltd. | Irrigation Tubing with CO2 or Air | 04/06/2020 |
| K140753 | MEDIVATORS | ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM | 07/15/2014 |
| K231418 | Medivators | ENDOGATORÖ Hybrid Irrigation Tubing | 08/14/2023 |
| K131426 | MEDLINE INDUSTRIES, INC. | MEDLINE BIOPSY VALVE | 02/21/2014 |
| K142068 | MEDOVATIONS, INC. | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE | 03/10/2015 |
| K203350 | Nissha Medical Technologies SAS | ENDOtube | 09/29/2021 |
| K964196 | NORTHGATE TECHNOLOGIES, INC. | CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) | 12/23/1996 |
| K993778 | NORTHGATE TECHNOLOGIES, INC. | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 | 01/06/2000 |
| K181457 | Partnership Medical Limited | EndoStream(TM) | 07/11/2019 |
| K181418 | Partnership Medical Limited | ScopeFlow Pure(TM) | 07/11/2019 |
| K193036 | PENTAX Medical, A Division of PENTAX of America, Inc. | C2 CryoBalloon EndoGrip | 11/22/2019 |
| K112318 | PROMEDIC, INC. | CLEARPATH 24 | 06/29/2012 |
| K152278 | PROMEPLA SAM | ENDOFLOW II - Irrigation, Warming and Suction System | 02/09/2016 |
| K222173 | Saneso, Inc. | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | 02/27/2023 |
| K182998 | Smartdata Suzhou Co., Ltd | Andorate Auxiliary Water Connector | 04/17/2019 |
| K181509 | Smartdata Suzhou Co., Ltd | Endorate Valve Sets | 07/06/2018 |
| K191366 | Smartdata Suzhou Co., Ltd | Vacutore Air/Water Bottle Tubing | 09/06/2019 |
| K122417 | THE RUHOF CORP. | SCOPEVALET DISPOSABLE BIOPSY VALVE | 05/17/2013 |
| K092461 | UNITED STATES ENDOSCOPY GROUP, INC. | IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 | 11/05/2009 |
| K103239 | UNITED STATES ENDOSCOPY GROUP, INC. | IRRIGATION SYSTEM | 12/30/2010 |
| K140405 | UNITED STATES ENDOSCOPY GROUP, INC. | TORRENT IRRIGATION SYSTEM | 03/12/2014 |
| K140315 | UNITED STATES ENDOSCOPY GROUP, INC. | US ENDOSCOPY DISTAL ATTACHMENT CAP | 04/04/2014 |
| K182319 | Wilson-Cook Medical, Inc. | Glo-Tip Spray Catheter | 02/01/2019 |
| K220785 | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Clean Connecting Tube | 09/27/2022 |
| K231471 | Zhejiang Chuangxiang Medical Technology Co., LTD. | Air/Water Bottle Tubing, CO2 Source Tubing | 09/08/2023 |
| K173758 | Zhejiang Chuangxiang Medical Technology Co., LTD. | Disposable Biopsy Valve | 05/14/2018 |
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