510(k) Report

Devices descending from K931154

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K181545Hysteroscope SystemShanghai AnQing Medical Instrument Co., Ltd.20192—
+7K181892Ziostation2Ziosoft, Inc.20181—
+7K181977WiScope Digital Endoscope SystemOTU Medical, Inc.20183—
+7K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.20175—
+7K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+7K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—
+7K150268CerOXOr-Nim Medical, Ltd.20150—
+7K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015371
+7K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation201419—
+7K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+7K071473Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd.200753—
+8K261447CVAC® Aspiration SystemCalyxo, Inc.20260—
+8K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation20260—
+8K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.20260—
+8K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+8K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+8K260965CVAC Aspiration SystemCalyxo, Inc.20260—
+8K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…Anhui Happiness Workshop Instruments Co., Ltd.20260—
+8K260013CVAC Image ProcessorCalyxo, Inc.20260—
+8K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…Guangzhou Red Pine Medical Instrument Co., Ltd.20251—
+8K250917Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model…Shenzhen Sanping Image Technology Co., Ltd.20250—
+8K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…Boston Scientific Corporation20250—
+8K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+8K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+8K243155Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03…Dongguan Zsr Biomedical Technology Company Limited20250—
+8K243117Digital Video ProcessorHunan Vathin Medical Instrument Co., Ltd.20250—
+8K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5…Hunan Endoso Life Technology Co., Ltd.20250—
+8K240203URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video…Dyne Medical Group, Inc.20240—
+8K233827OxiWearOxiwear, Inc.20240—
+8K241639Single-use Video Ureterorenoscope (SVU-220US)Huger Medical Instrument Co., Ltd.20240—
+8K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+8K240374Ureterorenoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+8K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+8K230778EndoCorePraxis Medical, LLC20230—
+8K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20231—
+8K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+8K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model…Shanghai AnQing Medical Instrument Co., Ltd.20223—
+8K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation20220—
+8K221952Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation20220—
+8K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+8K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+8K202445Hystero-V HysteroscopeHysterovue, Inc.20214—
+8K210270Medical Endoscope Image Processing SystemJiangsu Jiyuan Medical Technology Co., Ltd.20211—
+8K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+8K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+8K200315Ziostation2Ziosoft, Inc.20200—
+8K190797Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)Reed Medical (Zhejiang) Co., Ltd.20190—
+8K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+8K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+8K183020Endosee SystemCooperSurgical, Inc.201941
+8K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018291
+8K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+8K151275MAKO DeviceNvision Medical20152—
+8K110093Superdimension Marker Delivery KitSuperdimension, Inc.20114—
+8K102604I-Logic Inreach SystemSuperdimension, Ltd.20108—
+8K080271Inreach SystemSuperdimension, Ltd.200852—
+9K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…Guangzhou Red Pine Medical Instrument Co., Ltd.20260—
+9K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+9K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…Jiangsu Jiyuan Medical Technology Co., Ltd.20250—
+9K242699Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope…Opcom Medical, Inc.20250—
+9K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20251—
+9K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+9K232003Endoscopic Video Image Processor, Single-Use Video HysteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.20243—
+9K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+9K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20220—
+9K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+9K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+9K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+9K201432Masimo O3 Regional Oximeter SystemMasimo Corporation20202—
+9K190270FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc.201915—
+9K190639Endosee SystemCooperSurgical, Inc.201931
+9K160510MAKO 7Nvision Medical Corporation20161—
+9K151376superDimension Navigation SystemCovidien, LLC20152—
+9K081379Modification to Inreach SystemSuperdimension, Ltd.200845—
+10K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…Shanghai AnQing Medical Instrument Co., Ltd.20250—
+10K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+10K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+10K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…MacroLux Medical Technology Co., Ltd.20241—
+10K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+10K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+10K233216CLEWICU SystemClew Medical, Ltd.20240—
+10K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+10K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+10K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+10K214072Masimo O3 Regional Oximeter SystemMasimo Corporation20221—
+10K212219AHI SystemFifth Eye, Inc.20211—
+10K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+10K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+10K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+10K200038Endosee SystemCooperSurgical, Inc.20201—
+10K182975MAKO 7Boston Scientific Corporation20190—
+10K173244superDimension Navigation System V7.2Covidien, LLC20181—
+10K170023SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.2017015
+10K091934IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4…Veran Medical Technologies, Inc.20092—
+10K092365Inreach System, Model AAS00161-02Superdimension, Ltd.20099—
+10K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+10K082386Inreach Planning LaptopSuperdimension, Ltd.20080—
+11K260008Deterioration Index Version 2Epic Systems Corporation20260—
+11K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…Zhejiang Geyi Medical Instrument Co., Ltd.20260—