510(k) Report

Devices descending from K090116

45 later devices reach Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation20192—
+1K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC20167—
+1K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc.201519—
+1K122565Arc EndocuffBoddingtons Plastics, Ltd.20124—
+1K102616Naviaid Balloon Guided Colonoscopy (BGC) DeviceSmart Medical Systems, Ltd.20102—
+1K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+1K091773Fujinon Sterile OvertubesFujinon, Inc.20090—
+2K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation20240—
+2K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton20231—
+2K213773Insufflation Retention DeviceBpendo, LLC20221—
+2K213195Balloon BS-3Fujifilm Corporation20212—
+2K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation20195—
+2K173317DiLumen C2; DiLumen Tool MountLumendi, LLC20184—
+2K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc.20178—
+2K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd.20160—
+2K160846AmplifEYEMedivators, Inc.20160—
+2K153483Balloon controller PB-30Fujifilm Medical Systems U.S.A, Inc.20151—
+2K133359EndoringsEndo-Aid, Inc.20141—
+2K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+2K111760Naviaid (TM) BGC DeviceSmart Medical Systems, Ltd.20111—
+3K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+3K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLC20260—
+3K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.20260—
+3K242635Endoscopic Distal Attachment (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.20250—
+3K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation20243—
+3K232327EndorailEndostart S.R.L.20240—
+3K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation20231—
+3K211819DiLumen C2 and Tool MountLumendi, LLC20213—
+3K210915Pathfinder Endoscope CapNeptune Medical, Inc.20210—
+3K193123FUJIFILM Distal Cap Models 33-40Fujifilm Corporation20192—
+3K190030Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd.20190—
+3K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+3K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+3K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+3K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+4K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…Fujifilm Corporation20260—
+4K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation20250—
+4K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+4K242779Hood (DH-083ST)Fujifilm Corporation20240—
+4K221452DiLumen C1, EZ1 and Tool MountLumendi, LLC20232—
+4K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2Fujifilm Corporation20210—
+4K190669EndoticsEra Endoscopy S.R.L.20200—
+4K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+5K231323Ancora-SBAspero Medical, Inc.20231—
+6K260314Ancora-SBAspero Medical, Inc.20260—