510(k) Report

Devices descending from K001241

258 later devices reach Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190669EndoticsEra Endoscopy S.R.L.20200—
+1K151714Disposable Endoscope Valves Set AWilson Instruments (Shanghai) Company Limited20150—
+1K131855Pentax Video Colonoscopes (EC Family)Pentax Medical Company2014136
+1K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+1K102581Defendo Disposable Suction Valve Model 100305Byrne Medical, Inc.201022—
+1K102409Defendo Disposable Air/Water Valve Model 100304Byrne Medical, Inc.201021—
+1K070622Neoguide Endoscopy SystemNeoguide Systems, Inc.200712—
+1K052930Navigator Endoscopy SystemNeoguide Systems, Inc.200613—
+1K051645Evis Exera 160A SystemOlympus Medical Systems Corporation20052083
+1K051068Zutron Colonoscope Stiffening DeviceZutron Medical20051—
+1K051551Small Intestinal Videoscope SystemOlympus Medical Systems Corporation20054—
+1K043487Evis Exera Colonovideoscope Model XCF-Q160W1L/1Aizu Olympus Co., Ltd.20050—
+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—
+1K024033XTJF-160AF DuodenovideoscopeOlympus Optical Co., Ltd.200201
+2K260503Triton 1 SystemNeptune Medical, Inc.20260—
+2K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…Pentax of America, Inc.20250—
+2K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation20250—
+2K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)Pentax of America, Inc.20250—
+2K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope…Pentax of America, Inc.20240—
+2K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use…Medivators (A Subsidiary of Steris Corporation)20240—
+2K232004Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve…Medivators (A Subsidiary of Steris Corporation)20240—
+2K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation)20233—
+2K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.202314
+2K221331Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20220—
+2K210625JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps ValveFujifilm Medwork GmbH20211—
+2K210485PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC…Pentax of America, Inc.202102
+2K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd.20217—
+2K192048Single Use Endoscope Valves SetAnrei Medical (Hangzhou) Co., Ltd.20200—
+2K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+2K191231Andorate Auxiliary Water Connector, Andorate Valves SetSmartdata Suzhou Co., Ltd.20191—
+2K181084PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc.201932
+2K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesPentax Medical of America, Inc.20180—
+2K162330Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation201712
+2K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+2K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+2K160403SmartStart Air/Water and Suction ValvesEndochoice, Inc.20161—
+2K151522DEFENDO Bronchoscopy Suction ValveMedivators, Inc.20150—
+2K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+2K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+2K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp.201314Class I
+2K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+2K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+2K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576
+2K101053Olympus CF Type Y0023-L, Y0023IOlympus Medical Systems Corporation20100—
+2K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation20101329
+2K091962Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…Lumenis, Inc.200911—
+2K071254Small Intestinal Videoscope SystemOlympus Medical Systems Corporation200831
+2K072957Evis Exera II 180 SystemOlympus Medical Systems Corporation2008171
+2K070330Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.200713—
+2K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation2006158—
+2K061313Evis Exera 180 SystemOlympus Medical Systems Corporation2006158Class I
+3K252341Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20260—
+3K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+3K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation20260—
+3K252910Orca Air/Water and Suction ValvesBoston Scientific202501
+3K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+3K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation20250—
+3K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation202412
+3K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation20241—
+3K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C…Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+3K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+3K232118ANDORATE® Valve KitGa Health Company Limited20230—
+3K230332Ambu® aScope™ Colon; Ambu® aBox™ 2Ambu A/S20236—
+3K231323Ancora-SBAspero Medical, Inc.20231—
+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—
+3K220884Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited20231—
+3K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+3K220210Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd.20223—
+3K221264FROG Forceps Valve (VAL1-F1-100)Fujifilm Medwork GmbH20220—
+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—
+3K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+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—
+3K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+3K172036Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+3K162151PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20176—
+3K143727PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc.20153—
+3K140595Third Eye Panoramic Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.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—
+3K131028Pentax Video Bronchoscopes (EB Family)Pentax Medical Company201436
+3K131902Pentax Video Upper G.I. Scopes (EG Family)Pentax Medical Company2014102
+3K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+3K131422Peerscope SystemEndochoice, Inc.20132—
+3K131780Evis Exera Iii Video SystemOlympus Medical Systems Corp.201378
+3K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+3K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.201319—
+3K122831Video System CenterOlympus Medical Systems Corp.201219—
+3K123317Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190NOlympus Medical Systems Corporation20120—
+3K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp.2012341