510(k) Report

Devices descending from K021074

268 later devices reach Visera Cystovideoscope Olympus Cyf Type V/VA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210485PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC…Pentax of America, Inc.202102
+4K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd.20200—
+4K201200Visera Elite II Video System CenterOlympus Medical Systems Corp.20204—
+4K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+4K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+4K200397Single Use Biopsy Forceps FB-456DOlympus Medical Systems Corp.20200—
+4K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp.20201—
+4K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+4K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+4K190799PENTAX Medical Video Upper GI Scopes (EG Family)Pentax of America, Inc.20190—
+4K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.201901
+4K1836753D Visualization SystemScivita Medical Technology Co., Ltd.20190—
+4K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20192—
+4K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp.20192Class I
+4K181084PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc.201932
+4K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesPentax Medical of America, Inc.20180—
+4K180292PENTAX Video Upper G.I. Scope EG34-i10Pentax Medical of America, Inc.20180—
+4K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc.20182—
+4K180414EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc.20180—
+4K172796Flex Robotic System and Flex Transabdominal DriveMedrobotics Corporation20180—
+4K1728174K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EAOlympus Medical Systems Corp.20170—
+4K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc.201712—
+4K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc.20178—
+4K152182Fuse Gastroscopy SystemEndochoice, Inc.20151—
+4K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.20153—
+4K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc.20157—
+4K153049LithoVue SystemBoston Scientific Corporation201524—
+4K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc.20150—
+4K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation201591
+4K142556Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc.20147—
+4K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2013531
+4K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.200922—
+4K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc.200723—
+5K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.20260—
+5K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+5K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+5K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+5K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+5K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+5K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+5K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+5K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+5K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+5K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+5K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+5K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+5K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…Gyrus Acmi, Inc.20240—
+5K231497Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+5K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc.20241—
+5K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+5K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+5K223097RenaNav Ureteroscope SystemCenterPoint Systems, LLC20230—
+5K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+5K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Boston Scientific Corporation20234—
+5K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.20220—
+5K213334Monarch Platform, UrologyAuris Health, Inc.202201
+5K211686Flexible Video-Choledo-Cysto-Ureteroscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.20222—
+5K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+5K211347Uretero1 Ureteroscope SystemSTERIS Corporation20213—
+5K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+5K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—
+5K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc.202101
+5K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope…Olympus Medical Systems Corp.20211Class I
+5K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America20205—
+5K202957Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc.202012
+5K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+5K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—
+5K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+5K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+5K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+5K183188Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA…Richard Wolf Medical Instruments Corporation20191—
+5K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+5K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20189—
+5K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI…Lina Medical Aps20184—
+5K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.201723—
+5K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.20174—
+5K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+5K141250Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2014112
+5K123151Endosee Model 8000 U-ScopeEndosee Corp201320—
+5K093218Femeye TwoFem Suite, LLC20100—
+6K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…MacroLux Medical Technology Co., Ltd.20260—
+6K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+6K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+6K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…Zhejiang Geyi Medical Instrument Co., Ltd.20250—
+6K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+6K250049Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope…Seplou (Zhuhai) Co., Ltd.20250—
+6K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+6K243550KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)Karl Storz SE & CO. KG20250—
+6K250785Single-use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.20250—
+6K243894F88 URE-SD/RD Flexible UreteroscopeSg Endoscopy Pte, Ltd.20250—
+6K243532LumiRex UreteroscopeContra Healthcare Solutions, LLC20250—
+6K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…Scivita Medical Technology Co., Ltd.20251—
+6K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)Shanghai SeeGen Photoelectric Technology Co., Ltd.20240—
+6K240074Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2)…Shenzhen Besdata Technology Co., Ltd.20240—
+6K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+6K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video…Zhuhai Pusen Medical Technology Co., Ltd.20241—
+6K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…Boston Scientific Corporation20241—
+6K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+6K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc.20243Class I
+6K231135Video Ureteroscope SystemHunan Vathin Medical Instrument Co., Ltd.20241—