510(k) Report

Devices descending from K931154

652 later devices reach Evis 200 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K082174Y-AdapterAsthmatx, Inc.20080—
+4K080581VB Image ViewerOlympus Medical Systems Corporation20082—
+4K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc.20085—
+4K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+4K081233T-Stat 303 Ischemia Monitoring SystemSpectros Corporation200856—
+4K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859—
+4K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc.200781
+4K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc.200659—
+4K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies200613—
+4K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation200699—
+4K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.200563—
+4K052260Superdimension/Bronchus 4.1Superdimension, Ltd.2005562
+4K051585F-400 SystemMauna Kea Technologies200513—
+4K043275Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation200416—
+5K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+5K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+5K261015Solo Scope Colonoscope SystemGi View, Ltd.20260—
+5K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation20260—
+5K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation20260—
+5K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+5K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+5K260314Ancora-SBAspero Medical, Inc.20260—
+5K260009LungPoint Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Medical, Inc.20260—
+5K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.20260—
+5K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+5K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd.20260—
+5K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+5K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…Pentax of America, Inc.20250—
+5K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)Shenzhen Sophway Technology Co., Ltd.20250—
+5K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+5K251894Himaging Bronchscope SystemHimaging Technology (Shanghai) Co., Ltd.20250—
+5K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+5K250797UV5000 HandleUroviu Corporation20250—
+5K251823UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes…Zhejiang UE Medical Corp.20250—
+5K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+5K250232Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.20250—
+5K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20250Class I
+5K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20250—
+5K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable…Olympus Medical Systems Corporation20250—
+5K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0…Shenzhen Insighters Medical Technology Co., Ltd.20250—
+5K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas20252—
+5K243321Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+5K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+5K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+5K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)Pentax of America, Inc.20250—
+5K243196Uro-G HD Cystoscope (1520)Uroviu Corporation20240—
+5K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope…Pentax of America, Inc.20240—
+5K241371Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20240—
+5K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20241—
+5K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+5K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus…Medimaging Integrated Solution, Inc (Miis)20240—
+5K232435Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+5K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S20241—
+5K233779LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C)…MacroLux Medical Technology Co., Ltd.20240—
+5K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S20241—
+5K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+5K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20230—
+5K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+5K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S20234—
+5K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.202314
+5K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+5K230948BFlex™ 2 Slim 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20232—
+5K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation202321
+5K222910Bronchoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+5K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+5K222173Saneso Lens Wash Bottle Assembly (SAN-LWB-A)Saneso, Inc.20230—
+5K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+5K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+5K213235PENTAX Medical ONE Pulmo Single Use Video Bronchoscope SystemPentax of America, Inc.20221—
+5K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited20221—
+5K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3Olympus Medical Systems Corp.20220—
+5K213782Single-Use Video Bronchoscopes, Digital ControllerMicro-Tech (Nanjing) Co., Lts20220—
+5K214050ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis)20220—
+5K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope…OTU Medical, Inc.20220—
+5K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd.20220—
+5K211882HD-550 Video Endoscope SystemSonoscape Medical Corp.20221—
+5K211169Bronchoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20212—
+5K210928PENTAX Medical Video Bronchoscope EB11-J10Pentax of America, Inc.20210—
+5K210177PENTAX Medical Video Upper GI Scopes EG17-J10Pentax of America, Inc.20210—
+5K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.202101
+5K211030EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope…Boston Scientific Corporation20211—
+5K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…OTU Medical, Inc.20211—
+5K210883aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8Ambu A/S20212—
+5K210485PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC…Pentax of America, Inc.202102
+5K202180Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference…Axess Vision Technology20201—
+5K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd.20200—
+5K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesPentax of America, Inc.20200—
+5K201200Visera Elite II Video System CenterOlympus Medical Systems Corp.20204—
+5K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+5K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+5K200397Single Use Biopsy Forceps FB-456DOlympus Medical Systems Corp.20200—
+5K192691PatCom Single-Use IntroducerH&A Mui Enterprises, Inc.20200—
+5K191828Vathin Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.20208—
+5K190669EndoticsEra Endoscopy S.R.L.20200—
+5K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+5K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+5K190512SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareIntelligent Endoscopy20191—
+5K190799PENTAX Medical Video Upper GI Scopes (EG Family)Pentax of America, Inc.20190—
+5K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.201901
+5K1836753D Visualization SystemScivita Medical Technology Co., Ltd.20190—