510(k) Report

Devices descending from K963033

573 later devices reach BF 240/P240/IT240 Bronchovideoscope & Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+6K231267ClearTipFinemedix Co., Ltd.20231—
+6K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation202321
+6K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+6K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.20220—
+6K222014EXALT Model B Single-Use BronchoscopeBoston Scientific Corporation20220—
+6K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+6K212886Broncoflex Agile, Broncoflex Vortex, ScreeniAxess Vision Technology20220—
+6K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+6K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—
+6K210379Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20213—
+6K202727Peregrine Endoscopy System3nt Medical, Ltd.20210—
+6K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…OTU Medical, Inc.20211—
+6K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+6K202346SPiN Vision Video Bronchoscope SystemVeran Medical Technologies, Inc.20210—
+6K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope…Olympus Medical Systems Corp.20211Class I
+6K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America20205—
+6K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+6K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+6K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+6K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+6K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+6K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+6K192305Colibri Endoscopy System3nt Medical, Ltd.20200—
+6K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+6K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+6K190669EndoticsEra Endoscopy S.R.L.20200—
+6K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+6K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20192—
+6K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+6K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+6K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+6K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+6K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+6K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+6K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+6K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+6K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+6K153049LithoVue SystemBoston Scientific Corporation201524—
+6K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+6K142556Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc.20147—
+6K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+6K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+6K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+6K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2013531
+6K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+6K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+6K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+6K093923Cerox Model 3210Or-Nim Medical, Ltd.20100—
+6K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.200922—
+6K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc.200723—
+6K071473Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd.200753—
+7K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+7K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+7K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+7K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+7K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+7K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+7K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+7K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+7K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…Scivita Medical Technology Co., Ltd.20250—
+7K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)Scivita Medical Technology Co., Ltd.20240—
+7K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+7K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+7K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+7K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+7K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…Gyrus Acmi, Inc.20240—
+7K231497Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+7K231521Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20231—
+7K223097RenaNav Ureteroscope SystemCenterPoint Systems, LLC20230—
+7K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+7K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+7K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Boston Scientific Corporation20234—
+7K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+7K213334Monarch Platform, UrologyAuris Health, Inc.202201
+7K211686Flexible Video-Choledo-Cysto-Ureteroscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.20222—
+7K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+7K211347Uretero1 Ureteroscope SystemSTERIS Corporation20213—
+7K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc.202101
+7K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+7K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+7K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+7K202957Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc.202012
+7K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+7K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+7K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+7K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+7K183188Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA…Richard Wolf Medical Instruments Corporation20191—
+7K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+7K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20189—
+7K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI…Lina Medical Aps20184—
+7K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.201723—
+7K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.20174—
+7K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+7K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—