510(k) Report

Devices descending from K954451

318 later devices reach Evis 140 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation20260—
+1K123047Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing SetBracco Diagnostic, Inc.20130—
+1K051645Evis Exera 160A SystemOlympus Medical Systems Corporation20052083
+1K032177Gastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope XCF-Q14ML/I…Olympus Opto-Electronics Co., Ltd.200315—
+1K031256Xsif-1TQ140A Small Intestinal VideoscopeOlympus Opto-Electronics Co., Ltd.20035—
+1K023259Inhealth Soft Sleeve Colonoscope Splint, Model CS1200Helix Medical, Inc.20026—
+1K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+1K984358Olympus Distal Attachment, Models…Olympus America, Inc.1999302
+1K980465Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus…Olympus America, Inc.199822
+1K971660Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary…Olympus America, Inc.1997752
+2K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+2K243388Disposable Distal CapMicro-Tech (Nanjing) Co., Ltd.20251—
+2K250296Disposable Distal Attachment D-201 SeriesOlympus Medical Systems Corp.20251—
+2K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut typeSumitomo Bakelite Co., Ltd.20180—
+2K171673Focus CapGce Medical Corporation20180—
+2K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp.201314Class I
+2K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+2K122565Arc EndocuffBoddingtons Plastics, Ltd.20124—
+2K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+2K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576
+2K101053Olympus CF Type Y0023-L, Y0023IOlympus Medical Systems Corporation20100—
+2K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation20101329
+2K092221Colonic Splinting Overtube, Model 00711145United States Endoscopy Group, Inc.20095—
+2K091962Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…Lumenis, Inc.200911—
+2K072957Evis Exera II 180 SystemOlympus Medical Systems Corporation2008171
+2K070330Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.200713—
+2K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+2K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation2006158—
+2K061313Evis Exera 180 SystemOlympus Medical Systems Corporation2006158Class I
+2K051541GF-UE160-AL5 Ultrasound EndoscopeOlympus America, Inc.2005272
+2K051551Small Intestinal Videoscope SystemOlympus Medical Systems Corporation20054—
+2K050578Cook Ireland Duette Multi-Band Mucosectomy DeviceCook Ireland, Ltd.20054—
+2K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+2K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+2K024033XTJF-160AF DuodenovideoscopeOlympus Optical Co., Ltd.200201
+2K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc.2001601
+3K260503Triton 1 SystemNeptune Medical, Inc.20260—
+3K260856Disposable Distal Attachment D-201-13404Olympus Medical Systems Corporation20260—
+3K252341Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20260—
+3K253139Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd.20260—
+3K251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation20251—
+3K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation202412
+3K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C…Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+3K230332Ambu® aScope™ Colon; Ambu® aBox™ 2Ambu A/S20236—
+3K230588Aer-O-Scope Colonoscope SystemGi View, Ltd.20231—
+3K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100…Olympus Medical Systems Corporation20231—
+3K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited20230—
+3K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+3K210052Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without…Saneso, Inc.20221—
+3K212382Ambu® aScope™ Gastro, Ambu® aBox™2Ambu A/S20222—
+3K192704Endofresh Digestive Endoscopy SystemHuizhou Xzing Technology Co., Ltd.20200—
+3K201098Ambu Duodeno SystemAmbu Innovation GmbH20202—
+3K183416Rhino-Laryngo Videoscope Olympus ENF-VT3Olympus Medical Systems Corp.201901
+3K182102Rhino-Laryngo Videoscope Olympus Enf-VH2, Rhino-Laryngo Videoscope Olympus Enf-V4Olympus Medical Systems Corp.20191—
+3K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.20182—
+3K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DOlympus Medical Systems Corp.201872
+3K172246Olympus Urf-V2/V2ROlympus Medical Systems Corp.201823
+3K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+3K162151PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20176—
+3K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd.20160—
+3K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+3K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+3K160846AmplifEYEMedivators, Inc.20160—
+3K143727PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc.20153—
+3K140595Third Eye Panoramic Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.20142—
+3K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+3K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+3K133538Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope…Olympus Corporation of the Americas201425—
+3K140726Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator Emr Device for…Boston Scientific Corp20142—
+3K131028Pentax Video Bronchoscopes (EB Family)Pentax Medical Company201436
+3K131902Pentax Video Upper G.I. Scopes (EG Family)Pentax Medical Company2014102
+3K131855Pentax Video Colonoscopes (EC Family)Pentax Medical Company2014136
+3K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+3K133359EndoringsEndo-Aid, Inc.20141—
+3K131422Peerscope SystemEndochoice, Inc.20132—
+3K131780Evis Exera Iii Video SystemOlympus Medical Systems Corp.201378
+3K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+3K123013Endoscopic IntroducerNovadaq Technologies, Inc.20130—
+3K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.201319—
+3K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+3K122831Video System CenterOlympus Medical Systems Corp.201219—
+3K123317Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190NOlympus Medical Systems Corporation20120—
+3K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+3K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+3K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp.2012341
+3K111756V1 SystemOlympus Medical Systems Corp.201202
+3K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc.20110—
+3K100081Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc.20103—
+3K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+3K083180Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.20095—
+3K082174Y-AdapterAsthmatx, Inc.20080—
+3K071254Small Intestinal Videoscope SystemOlympus Medical Systems Corporation200831
+3K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+3K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc.200781
+3K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+3K043275Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation200416—
+3K021204Olympus BF Type UM40Olympus Optical Co., Ltd.200244—
+4K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+4K261015Solo Scope Colonoscope SystemGi View, Ltd.20260—
+4K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation20260—