510(k) Report

Devices descending from K051541

27 later devices reach GF-UE160-AL5 Ultrasound Endoscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation20251—
+1K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc.200781
+1K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+2K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation20260—
+2K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+2K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc.201241
+2K111243Fujinon Ultrasonic ProcessorFujinon, Inc.20117—
+2K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+3K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+3K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+3K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20183—
+3K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc.20161—
+3K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+3K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+4K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+4K200850Fujifilm Ultrasonic ProcessorFujifilm Corporation20200—
+4K183433FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20192—
+4K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+4K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+4K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+4K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+4K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+5K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation20220—
+5K221952Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation20220—
+5K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+5K190669EndoticsEra Endoscopy S.R.L.20200—
+5K173085invendoscopy E210 SystemInvendo Medical GmbH20180—