510(k) Report

Devices descending from K042043

39 later devices reach Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc.20156—
+1K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc.201425—
+1K063316Fujinon Model EG-530N Trans Nasal InsertionFujinon, Inc.200710—
+2K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+2K210162Endoscope Model EI-740D/SFujifilm Corporation20215—
+2K182836FUJIFILM Endoscope Model EG-740NFujifilm Corporation20194—
+2K183686FUJIFILM Endoscope Model EG-530NFujifilm Corporation20190—
+2K180341FUJIFILM 600 Series Endoscope EG-600WR v2Fujifilm Corporation20181—
+2K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM…Fujifilm Corporation201818—
+2K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc.201619—
+2K143732FUJIFILM Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc.20152—
+3K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+3K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.20260—
+3K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+3K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+3K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+3K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+3K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation20243—
+3K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation)20233—
+3K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+3K221551FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton20232—
+3K213095andorate Suction Valve, andorate Air/Water ValveGa Health Company Limited20220—
+3K200495Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveGa Health Company Limited20201—
+3K200388Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer ConnectorGa Health Company Limited20200—
+3K192664FUJIFILM Endoscope Model EC-760Z-V/LFujifilm Corporation20190—
+3K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFujifilm Corporation20195—
+3K190649FUJIFILM Endoscope Model EC-760S-V/LFujifilm Corporation20193—
+3K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc.20161—
+4K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation20260—
+4K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+4K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+4K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation20250—
+4K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation20250—
+4K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation20240—
+4K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation20241—
+4K232118ANDORATE® Valve KitGa Health Company Limited20230—
+4K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01Fujifilm Corporation20231—
+4K180405FUJIFILM Endoscope Models EC-600HL and EC-600LSFujifilm Corporation20180—
+5K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…STERIS Corporation20240—