510(k) Report

Devices descending from K031773

58 later devices reach Endo Gator System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092429EndogatorByrne Medical, Inc.200941—
+1K092461Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140United States Endoscopy Group, Inc.200901
+1K091305ClearpathEasyglide, Ltd.200913—
+1K063700Spyglass Irrigation SystemMedical Scientific, Inc.20070—
+1K033695Irrigation Channel Tubing, Model 100135Byrne Medical, Inc.20031—
+2K232004Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve…Medivators (A Subsidiary of Steris Corporation)20240—
+2K220395EndoGator Endoscopy Irrigation TubingSTERIS Corporation20227—
+2K203350ENDOtubeNissha Medical Technologies Sas20211—
+2K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd.20217—
+2K202560AquaPulse Irrigation TubingGa Health Company Limited20202—
+2K200479AquaPulse Auxiliary Water ConnectorGa Health Company Limited20201—
+2K181457EndoStream (TM)Partnership Medical Limited20190—
+2K191231Andorate Auxiliary Water Connector, Andorate Valves SetSmartdata Suzhou Co., Ltd.20191—
+2K120862Water Bottle Cap Irrigaton SystemEndochoice, Inc.20123—
+2K112318Clearpath 24Promedic, Inc.20120—
+2K113050Clearpath Lower GIEasyglide, Ltd.20128—
+2K110088Defendo Y-Opsy IrrigatorByrne Medical Incorporated20112—
+2K103696Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesErbe USA, Inc.20113—
+2K102855Universal Irrigation Solution HybridByrne Medical, Inc.20107—
+2K101094ClearjetEasyglide, Ltd.20100—
+2K093779Clearpath UgiEasyglide, Ltd.201010—
+3K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+3K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use…Medivators (A Subsidiary of Steris Corporation)20240—
+3K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation)20233—
+3K230773Endoscopy Irrigation TubingZhejiang Chuangxiang Medical Technology Co., Ltd.20230—
+3K232118ANDORATE® Valve KitGa Health Company Limited20230—
+3K231418ENDOGATOR™ Hybrid Irrigation TubingMedivators20230—
+3K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingGa Health Company Limited20230—
+3K220884Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited20231—
+3K223171AquaPulse® Irrigation TubingGa Health Company Limited20220—
+3K221310Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source TubingChangzhou Endoclean Medical Device Co., Ltd.20220—
+3K220785Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., Ltd.20220—
+3K221331Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20220—
+3K221177Erbe's Tubing/Cap SetsErbe USA, Inc.202201
+3K220210Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd.20223—
+3K200481Andorate Biopsy Valve, Andorate Biopsy IrrigatorGa Health Company Limited20201—
+3K193250Irrigation Tubing with CO2 or AirKeymed (Medical and Industrial Equipment), Ltd.20200—
+3K160015Pure VuMotus GI Medical Technologies, Ltd.20167—
+3K133747Endochoice Water Bottle Cap Irrigation SystemEndochoice, Inc.20142—
+3K132340Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…Erbe USA, Inc.201321
+3K113166Clearpath Upper GIEasyglide, Ltd.20120—
+4K250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.20250—
+4K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation20250—
+4K241285Disposable Endoscope Valves Set (AF series)Alton (Shanghai) Medical Instruments Co., Ltd.20240—
+4K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation20241—
+4K222499Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co., Ltd.20230—
+4K230932ANDORATE® Valve KitGa Health Company Limited20230—
+4K222980Pentax Medical Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.20220—
+4K173392Pure-Vu SystemMotus GI Medical Technologies, Ltd.20176—
+4K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.201611
+4K161482EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc.20161—
+5K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…STERIS Corporation20240—
+5K181437Pure Vu SystemMotus GI Medical Technologies, Ltd.20185—
+6K191220Pure Vu SystemMotus GI Medical Technologies, Ltd.20194—
+7K220007Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd.20222—
+7K210981Pure Vu SystemMotus GI Medical Technologies, Ltd.20210—
+8K232922Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd.20231—
+9K240853Pathfinder® CR SystemNeptune Medical, Inc.20240—