510(k) Report

Devices descending from K790071

26 later devices reach Endoscope and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093665Endo SmartcapByrne Medical, Inc.2009187
+1K992141Olympus Working Element for ProbesOlympus Winter & Ibe GmbH19992—
+1K990237Trocar System According to HassonOlympus America, Inc.19990—
+1K983811Unipolar Optical Biopsy ForcepsOlympus Winter & Ibe GmbH19981—
+1K950719Oes UrologyOlympus America, Inc.19960—
+2K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems Corporation20240—
+2K231471Air/Water Bottle Tubing, CO2 Source TubingZhejiang Chuangxiang Medical Technology Co., Ltd.20230—
+2K223040Endo SmartCapMedivators, Inc.20230—
+2K203350ENDOtubeNissha Medical Technologies Sas20211—
+2K200388Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer ConnectorGa Health Company Limited20200—
+2K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.201901
+2K171916Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp.20170—
+2K140753Endo Smart Bottle, Rinse and Insufflation SystemMedivators20141—
+2K103696Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesErbe USA, Inc.20113—
+2K102855Universal Irrigation Solution HybridByrne Medical, Inc.20107—
+2K050910Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd.20051—
+3K231418ENDOGATOR™ Hybrid Irrigation TubingMedivators20230—
+3K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingGa Health Company Limited20230—
+3K221310Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source TubingChangzhou Endoclean Medical Device Co., Ltd.20220—
+3K220785Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., Ltd.20220—
+3K221177Erbe's Tubing/Cap SetsErbe USA, Inc.202201
+3K193250Irrigation Tubing with CO2 or AirKeymed (Medical and Industrial Equipment), Ltd.20200—
+3K181418ScopeFlow Pure (TM)Partnership Medical Limited20190—
+3K132340Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…Erbe USA, Inc.201321
+3K053322Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd.20060—
+4K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.201611