510(k) Report

Devices descending from K944620

125 later devices reach Series 400 Gastroenterology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc.201425—
+1K102466Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc.201137—
+1K042043Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Fujinon, Inc.200439—
+1K042076Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5Fujinon, Inc.200464
+1K041903Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc.2004751
+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—
+2K152257Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc.201753
+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—
+2K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc.20156—
+2K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+2K131953IMAGE1 SpiesKARL STORZ Endoscopy-America, Inc.2013101
+2K112391Fujinon ColonoscopesFujinon, Inc.201233—
+2K113873Pentax Epk-I5020 Video ProcessorPentax of America, Inc.20127—
+2K111997IMAGE1 GI Ccu Model 22203020-114KARL STORZ Endoscopy-America, Inc.20120—
+2K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc.200945—
+2K063316Fujinon Model EG-530N Trans Nasal InsertionFujinon, Inc.200710—
+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—
+3K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KHGuangdong Optomedic Technologies, Inc.20230—
+3K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+3K213095andorate Suction Valve, andorate Air/Water ValveGa Health Company Limited20220—
+3K210162Endoscope Model EI-740D/SFujifilm Corporation20215—
+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—
+3K182836FUJIFILM Endoscope Model EG-740NFujifilm Corporation20194—
+3K190648Pusen Eview Medical Video Endoscope Image ProcessorZhuhai Pusen Medical Technology Co., Ltd.20191—
+3K181745FUJIFILM Duodenoscope ModelFujifilm Corporation20193—
+3K183686FUJIFILM Endoscope Model EG-530NFujifilm Corporation20190—
+3K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation20192—
+3K182051FUJIFILM Duodenoscope ModelFujifilm Corporation20180—
+3K180414EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc.20180—
+3K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc.201712—
+3K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc.20178—
+3K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC20167—
+3K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc.20161—
+3K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc.20166—
+3K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc.20150—
+3K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc.201519—
+3K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+3K122565Arc EndocuffBoddingtons Plastics, Ltd.20124—
+3K102616Naviaid Balloon Guided Colonoscopy (BGC) DeviceSmart Medical Systems, Ltd.20102—
+3K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+3K091773Fujinon Sterile OvertubesFujinon, Inc.20090—
+4K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+4K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.20260—
+4K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+4K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+4K251734ProVee Video Processing Unit (PV-003)Proverum Limited20250—
+4K250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.20250—
+4K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+4K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+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—
+4K221551FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton20232—
+4K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton20231—
+4K213773Insufflation Retention DeviceBpendo, LLC20221—
+4K213195Balloon BS-3Fujifilm Corporation20212—
+4K201135Image1 S CCU, Image1 S 4U Camera HeadKARL STORZ Endoscopy-America, Inc.20204—
+4K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+4K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+4K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+4K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.201901
+4K191747FUJIFILM Duodenoscope Model ED-580XTFujifilm Corporation20192—
+4K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation20195—
+4K173317DiLumen C2; DiLumen Tool MountLumendi, LLC20184—
+4K180405FUJIFILM Endoscope Models EC-600HL and EC-600LSFujifilm Corporation20180—
+4K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc.20178—
+4K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd.20160—
+4K160846AmplifEYEMedivators, Inc.20160—
+4K153483Balloon controller PB-30Fujifilm Medical Systems U.S.A, Inc.20151—
+4K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.20153—
+4K133359EndoringsEndo-Aid, Inc.20141—
+4K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+4K111760Naviaid (TM) BGC DeviceSmart Medical Systems, Ltd.20111—
+5K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation20260—
+5K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLC20260—
+5K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+5K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+5K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.20260—
+5K250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private Limited20250—
+5K242635Endoscopic Distal Attachment (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.20250—
+5K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…STERIS Corporation20240—
+5K232327EndorailEndostart S.R.L.20240—
+5K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+5K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+5K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation20231—
+5K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.202314
+5K211819DiLumen C2 and Tool MountLumendi, LLC20213—