510(k) Report

Devices descending from K093665

18 later devices reach Endo Smartcap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems Corporation20240—
+1K231471Air/Water Bottle Tubing, CO2 Source TubingZhejiang Chuangxiang Medical Technology Co., Ltd.20230—
+1K223040Endo SmartCapMedivators, Inc.20230—
+1K203350ENDOtubeNissha Medical Technologies Sas20211—
+1K200388Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer ConnectorGa Health Company Limited20200—
+1K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.201901
+1K140753Endo Smart Bottle, Rinse and Insufflation SystemMedivators20141—
+1K103696Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesErbe USA, Inc.20113—
+1K102855Universal Irrigation Solution HybridByrne Medical, Inc.20107—
+2K231418ENDOGATOR™ Hybrid Irrigation TubingMedivators20230—
+2K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingGa Health Company Limited20230—
+2K221310Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source TubingChangzhou Endoclean Medical Device Co., Ltd.20220—
+2K220785Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., Ltd.20220—
+2K221177Erbe's Tubing/Cap SetsErbe USA, Inc.202201
+2K193250Irrigation Tubing with CO2 or AirKeymed (Medical and Industrial Equipment), Ltd.20200—
+2K181418ScopeFlow Pure (TM)Partnership Medical Limited20190—
+2K132340Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…Erbe USA, Inc.201321
+3K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.201611