510(k) Report

Devices descending from K931154

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202957Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc.202012
+6K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+6K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—
+6K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+6K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+6K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+6K192305Colibri Endoscopy System3nt Medical, Ltd.20200—
+6K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+6K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+6K191078BAROnova Access Sheath KitBaronova, Inc.20190—
+6K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+6K183188Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA…Richard Wolf Medical Instruments Corporation20191—
+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—
+6K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+6K182846PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc.20192—
+6K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20183—
+6K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20189—
+6K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+6K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI…Lina Medical Aps20184—
+6K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+6K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+6K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.201723—
+6K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.20174—
+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—
+6K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc.20161—
+6K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+6K150083Sidecar External Working ChannelC2 Therapeutics20150—
+6K141250Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2014112
+6K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+6K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+6K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+6K123151Endosee Model 8000 U-ScopeEndosee Corp201320—
+6K121449DirectpathCybernet Systems Co., Ltd.20120—
+6K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+6K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+6K112051Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc.20113—
+6K093218Femeye TwoFem Suite, LLC20100—
+6K093923Cerox Model 3210Or-Nim Medical, Ltd.20100—
+6K093423Lungpoint Procedure PlanningBroncus Technologies, Inc.20091—
+6K093187Modification to Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.20093—
+6K062315Superdimension/Bronchus Premium 2Superdimension, Ltd.2006541
+7K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+7K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+7K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…MacroLux Medical Technology Co., Ltd.20260—
+7K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+7K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+7K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+7K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…Zhejiang Geyi Medical Instrument Co., Ltd.20250—
+7K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+7K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+7K250049Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope…Seplou (Zhuhai) Co., Ltd.20250—
+7K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+7K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+7K243550KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)Karl Storz SE & CO. KG20250—
+7K250785Single-use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.20250—
+7K243894F88 URE-SD/RD Flexible UreteroscopeSg Endoscopy Pte, Ltd.20250—
+7K243532LumiRex UreteroscopeContra Healthcare Solutions, LLC20250—
+7K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…Scivita Medical Technology Co., Ltd.20251—
+7K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…Scivita Medical Technology Co., Ltd.20250—
+7K243380Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20250—
+7K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)Scivita Medical Technology Co., Ltd.20240—
+7K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)Shanghai SeeGen Photoelectric Technology Co., Ltd.20240—
+7K240074Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2)…Shenzhen Besdata 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—
+7K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video…Zhuhai Pusen Medical Technology Co., Ltd.20241—
+7K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…Boston Scientific Corporation20241—
+7K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc.20243Class I
+7K231135Video Ureteroscope SystemHunan Vathin Medical Instrument Co., Ltd.20241—
+7K231774CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital…MacroLux Medical Technology Co., Ltd.20240—
+7K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…Boston Scientific Corporation -202331
+7K231521Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20231—
+7K230475Medical Video Endoscope SystemHuger Medical Instrument Co., Ltd.20232—
+7K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible…Zhuhai Pusen Medical Technology Co., Ltd.20230—
+7K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+7K230200Single-Use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.20232—
+7K221158Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd.20233—
+7K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+7K223466Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20232—
+7K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+7K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+7K212458Flexible Video-Uretero-Renoscope SSU SystemKarl Storz Endoscopy America20220—
+7K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+7K201897Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525Richard Wolf Medical Instruments Corporation20210—
+7K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+7K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+7K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+7K201293Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20204—
+7K200850Fujifilm Ultrasonic ProcessorFujifilm Corporation20200—
+7K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+7K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+7K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+7K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording…Lina Medical Aps20200—
+7K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+7K183433FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20192—