510(k) Report

Devices descending from K884836

59 later devices reach Universal Generator Irrigator Model Ugi-3000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031773Endo Gator SystemByrne Medical, Inc.200358—
+2K092429EndogatorByrne Medical, Inc.200941—
+2K092461Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140United States Endoscopy Group, Inc.200901
+2K091305ClearpathEasyglide, Ltd.200913—
+2K063700Spyglass Irrigation SystemMedical Scientific, Inc.20070—
+2K033695Irrigation Channel Tubing, Model 100135Byrne Medical, Inc.20031—
+3K232004Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve…Medivators (A Subsidiary of Steris Corporation)20240—
+3K220395EndoGator Endoscopy Irrigation TubingSTERIS Corporation20227—
+3K203350ENDOtubeNissha Medical Technologies Sas20211—
+3K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd.20217—
+3K202560AquaPulse Irrigation TubingGa Health Company Limited20202—
+3K200479AquaPulse Auxiliary Water ConnectorGa Health Company Limited20201—
+3K181457EndoStream (TM)Partnership Medical Limited20190—
+3K191231Andorate Auxiliary Water Connector, Andorate Valves SetSmartdata Suzhou Co., Ltd.20191—
+3K120862Water Bottle Cap Irrigaton SystemEndochoice, Inc.20123—
+3K112318Clearpath 24Promedic, Inc.20120—
+3K113050Clearpath Lower GIEasyglide, Ltd.20128—
+3K110088Defendo Y-Opsy IrrigatorByrne Medical Incorporated20112—
+3K103696Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesErbe USA, Inc.20113—
+3K102855Universal Irrigation Solution HybridByrne Medical, Inc.20107—
+3K101094ClearjetEasyglide, Ltd.20100—
+3K093779Clearpath UgiEasyglide, Ltd.201010—
+4K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+4K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use…Medivators (A Subsidiary of Steris Corporation)20240—
+4K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation)20233—
+4K230773Endoscopy Irrigation TubingZhejiang Chuangxiang Medical Technology Co., Ltd.20230—
+4K232118ANDORATE® Valve KitGa Health Company Limited20230—
+4K231418ENDOGATOR™ Hybrid Irrigation TubingMedivators20230—
+4K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingGa Health Company Limited20230—
+4K220884Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited20231—
+4K223171AquaPulse® Irrigation TubingGa Health Company Limited20220—
+4K221310Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source TubingChangzhou Endoclean Medical Device Co., Ltd.20220—
+4K220785Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., Ltd.20220—
+4K221331Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20220—
+4K221177Erbe's Tubing/Cap SetsErbe USA, Inc.202201
+4K220210Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd.20223—
+4K200481Andorate Biopsy Valve, Andorate Biopsy IrrigatorGa Health Company Limited20201—
+4K193250Irrigation Tubing with CO2 or AirKeymed (Medical and Industrial Equipment), Ltd.20200—
+4K160015Pure VuMotus GI Medical Technologies, Ltd.20167—
+4K133747Endochoice Water Bottle Cap Irrigation SystemEndochoice, Inc.20142—
+4K132340Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…Erbe USA, Inc.201321
+4K113166Clearpath Upper GIEasyglide, Ltd.20120—
+5K250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.20250—
+5K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation20250—
+5K241285Disposable Endoscope Valves Set (AF series)Alton (Shanghai) Medical Instruments Co., Ltd.20240—
+5K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation20241—
+5K222499Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co., Ltd.20230—
+5K230932ANDORATE® Valve KitGa Health Company Limited20230—
+5K222980Pentax Medical Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.20220—
+5K173392Pure-Vu SystemMotus GI Medical Technologies, Ltd.20176—
+5K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.201611
+5K161482EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc.20161—
+6K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…STERIS Corporation20240—
+6K181437Pure Vu SystemMotus GI Medical Technologies, Ltd.20185—
+7K191220Pure Vu SystemMotus GI Medical Technologies, Ltd.20194—
+8K220007Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd.20222—
+8K210981Pure Vu SystemMotus GI Medical Technologies, Ltd.20210—
+9K232922Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd.20231—
+10K240853Pathfinder® CR SystemNeptune Medical, Inc.20240—