510(k) Report

Devices descending from K931154

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K192322T-Stat 2.0 Microvascular Tissue OximeterSpectros Corporation20190—
+5K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20192—
+5K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp.20192Class I
+5K183691PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20192—
+5K190030Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd.20190—
+5K181084PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc.201932
+5K181451Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7ROlympus Medical Systems Corp.201911
+5K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+5K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesPentax Medical of America, Inc.20180—
+5K180292PENTAX Video Upper G.I. Scope EG34-i10Pentax Medical of America, Inc.20180—
+5K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+5K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc.20182—
+5K180911Visura Technologies TEECAD SystemVisura Technologies, LLC20180—
+5K180414EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc.20180—
+5K172156PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical20183—
+5K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+5K172796Flex Robotic System and Flex Transabdominal DriveMedrobotics Corporation20180—
+5K1728174K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EAOlympus Medical Systems Corp.20170—
+5K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc.201712—
+5K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+5K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc.20178—
+5K1629163NT endoscopy system3nt Medical, Ltd.20173—
+5K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc.20160—
+5K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+5K152922ViziShot FLEXSpiration, Inc.20166—
+5K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+5K152182Fuse Gastroscopy SystemEndochoice, Inc.20151—
+5K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.20153—
+5K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc.20157—
+5K153049LithoVue SystemBoston Scientific Corporation201524—
+5K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc.20150—
+5K142556Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc.20147—
+5K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+5K133466Cellvizio 100 Series System with Confocal Miniprobes (TM)Mauna Kea Technologies20147—
+5K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+5K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+5K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2013531
+5K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+5K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc.201241
+5K110531Endoflip EcdCrospon, Ltd.20111—
+5K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc.201112—
+5K111243Fujinon Ultrasonic ProcessorFujinon, Inc.20117—
+5K102366Finess EndoscopeEntellus Medical, Inc.20110—
+5K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053—
+5K102715Regional OximeterNonin Medical, Inc.201053—
+5K093810BF-NaviKgt, Inc.20101—
+5K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.200922—
+5K091783Third Eye Retroscope Auxiliary Endoscope SystemAvantis Medical Systems, Inc.20094—
+5K091160Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20095—
+5K073407PacificaOr-Nim Medical, Ltd.20081—
+5K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc.200723—
+5K052852Superdimension/Bronchus PremiumSuperdimension, Ltd.2005551
+6K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.20260—
+6K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.20260—
+6K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+6K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+6K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+6K250145Biopsy Port AdapterEndosound, Inc.20250—
+6K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+6K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+6K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+6K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US…Shanghai AnQing Medical Instrument Co., Ltd.20251—
+6K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+6K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+6K243541LumiRex BronchoscopeContra Healthcare Solutions, LLC20250—
+6K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+6K242010Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8…Shenzhen Sanping Image Technology Co., Ltd.20250—
+6K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…Hunan Vathin Medical Instrument Co., Ltd.20250—
+6K241612Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L…Hunan Vathin Medical Instrument Co., Ltd.20240—
+6K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+6K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+6K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…Gyrus Acmi, Inc.20240—
+6K231497Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+6K231107Bronchoscope SystemHunan Endoso Life Technology Co., Ltd.20241—
+6K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc.20241—
+6K231970PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…Pentax of America, Inc.20240—
+6K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceAmbu A/S20242—
+6K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+6K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+6K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S202311
+6K223097RenaNav Ureteroscope SystemCenterPoint Systems, LLC20230—
+6K231267ClearTipFinemedix Co., Ltd.20231—
+6K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Boston Scientific Corporation20234—
+6K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT…Pentax of America, Inc.20221—
+6K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.20220—
+6K222014EXALT Model B Single-Use BronchoscopeBoston Scientific Corporation20220—
+6K213334Monarch Platform, UrologyAuris Health, Inc.202201
+6K211686Flexible Video-Choledo-Cysto-Ureteroscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.20222—
+6K212886Broncoflex Agile, Broncoflex Vortex, ScreeniAxess Vision Technology20220—
+6K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+6K211347Uretero1 Ureteroscope SystemSTERIS Corporation20213—
+6K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+6K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P…STERIS Corporation20210—
+6K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc.202101
+6K210379Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20213—
+6K202727Peregrine Endoscopy System3nt Medical, Ltd.20210—
+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—