510(k) Report

Devices descending from K011151

218 later devices reach Evis Exera Gastrointestinal Videoscope Gif-Q160Z through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+4K221690Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R)…Olympus Medical Systems Corp.202203
+4K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3Olympus Medical Systems Corp.20220—
+4K211882HD-550 Video Endoscope SystemSonoscape Medical Corp.20221—
+4K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+4K210928PENTAX Medical Video Bronchoscope EB11-J10Pentax of America, Inc.20210—
+4K210177PENTAX Medical Video Upper GI Scopes EG17-J10Pentax of America, Inc.20210—
+4K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+4K210485PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC…Pentax of America, Inc.202102
+4K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…Schoelly Fiberoptic GmbH20210—
+4K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America20205—
+4K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesPentax of America, Inc.20200—
+4K201200Visera Elite II Video System CenterOlympus Medical Systems Corp.20204—
+4K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.20200—
+4K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+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—
+4K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+4K190669EndoticsEra Endoscopy S.R.L.20200—
+4K190799PENTAX Medical Video Upper GI Scopes (EG Family)Pentax of America, Inc.20190—
+4K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp.20192Class I
+4K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head…Olympus Medical Systems Corp.20195—
+4K183691PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20192—
+4K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc.20190—
+4K182723Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20193—
+4K181084PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc.201932
+4K181451Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7ROlympus Medical Systems Corp.201911
+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—
+4K172156PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical20183—
+4K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+4K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc.20178—
+4K162332Nexcore GI InsufflatorNexcore Technology, LLC20160—
+4K160766Ambu USR, Ambu MAmbu A/S201614—
+4K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+4K152182Fuse Gastroscopy SystemEndochoice, Inc.20151—
+4K151011Visera 4K Uhd SystemOlympus Medical Systems Corp.20153—
+4K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc.20150—
+4K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+5K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+5K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation20260—
+5K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+5K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+5K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd.20260—
+5K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+5K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+5K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)Shenzhen Sophway Technology Co., Ltd.20250—
+5K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+5K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+5K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20250—
+5K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+5K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas20252—
+5K243321Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+5K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…Hunan Vathin Medical Instrument Co., Ltd.20250—
+5K241612Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L…Hunan Vathin Medical Instrument Co., Ltd.20240—
+5K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+5K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc.20241—
+5K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+5K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceAmbu A/S20242—
+5K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S202311
+5K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+5K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT…Pentax of America, Inc.20221—
+5K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.20220—
+5K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—
+5K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+5K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope…Olympus Medical Systems Corp.20211Class I
+5K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+5K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd.20200—
+5K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+5K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+5K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+5K193095Ambu aScope 4 CystoAmbu A/S202013—
+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—
+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—
+6K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.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—
+6K251140Zenflow Spring ScopeZenflow, Inc.20250—
+6K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+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—
+6K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+6K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+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—
+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—