510(k) Report

Devices descending from K001241

258 later devices reach Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd.20200—
+5K201200Visera Elite II Video System CenterOlympus Medical Systems Corp.20204—
+5K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+5K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+5K193095Ambu aScope 4 CystoAmbu A/S202013—
+5K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+5K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20192—
+5K191078BAROnova Access Sheath KitBaronova, Inc.20190—
+5K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+5K182846PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc.20192—
+5K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+5K1728174K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EAOlympus Medical Systems Corp.20170—
+5K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+5K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+5K093187Modification to Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.20093—
+6K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+6K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.20260—
+6K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+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—
+6K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+6K251140Zenflow Spring ScopeZenflow, Inc.20250—
+6K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+6K243380Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20250—
+6K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…Hunan Vathin Medical Instrument Co., Ltd.20240—
+6K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps20240—
+6K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+6K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+6K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+6K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxMedimaging Integrated Solution, Inc (Miis)20230—
+6K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+6K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+6K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20221—
+6K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd.20221—
+6K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20221—
+6K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc.202101
+6K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+6K202957Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc.202012
+6K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+6K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+6K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+6K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+7K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+7K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+7K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+7K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+7K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+7K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+7K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+7K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+7K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+8K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+8K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+9K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+10K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—