510(k) Report

Devices descending from K051645

208 later devices reach Evis Exera 160A System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K181451Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7ROlympus Medical Systems Corp.201911
+3K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesPentax Medical of America, Inc.20180—
+3K180292PENTAX Video Upper G.I. Scope EG34-i10Pentax Medical of America, Inc.20180—
+3K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc.20182—
+3K180414EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc.20180—
+3K172156PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical20183—
+3K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+3K172796Flex Robotic System and Flex Transabdominal DriveMedrobotics Corporation20180—
+3K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc.201712—
+3K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc.20178—
+3K160766Ambu USR, Ambu MAmbu A/S201614—
+3K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+3K152182Fuse Gastroscopy SystemEndochoice, Inc.20151—
+3K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.20153—
+3K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc.20157—
+3K151011Visera 4K Uhd SystemOlympus Medical Systems Corp.20153—
+3K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc.20150—
+3K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+4K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation20260—
+4K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+4K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+4K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd.20260—
+4K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+4K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)Shenzhen Sophway Technology Co., Ltd.20250—
+4K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+4K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+4K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+4K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20250—
+4K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+4K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+4K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+4K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+4K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas20252—
+4K243321Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+4K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…Hunan Vathin Medical Instrument Co., Ltd.20250—
+4K241612Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L…Hunan Vathin Medical Instrument Co., Ltd.20240—
+4K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+4K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc.20241—
+4K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+4K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceAmbu A/S20242—
+4K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+4K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+4K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S202311
+4K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT…Pentax of America, Inc.20221—
+4K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.20220—
+4K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+4K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+4K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—
+4K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope…Olympus Medical Systems Corp.20211Class I
+4K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America20205—
+4K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd.20200—
+4K201200Visera Elite II Video System CenterOlympus Medical Systems Corp.20204—
+4K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+4K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+4K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+4K193095Ambu aScope 4 CystoAmbu A/S202013—
+4K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+4K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20192—
+4K191078BAROnova Access Sheath KitBaronova, Inc.20190—
+4K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+4K182846PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc.20192—
+4K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+4K1728174K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EAOlympus Medical Systems Corp.20170—
+4K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+4K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+5K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+5K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.20260—
+5K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm 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—
+5K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+5K251140Zenflow Spring ScopeZenflow, Inc.20250—
+5K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+5K243380Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20250—
+5K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…Hunan Vathin Medical Instrument Co., Ltd.20240—
+5K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps20240—
+5K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+5K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+5K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+5K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxMedimaging Integrated Solution, Inc (Miis)20230—
+5K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+5K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+5K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20221—
+5K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd.20221—
+5K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20221—
+5K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc.202101
+5K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+5K202957Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc.202012
+5K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+5K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+5K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+5K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+5K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+6K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+6K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+6K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+6K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+6K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+6K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—