510(k) Report

Devices descending from K972114

213 later devices reach Olympus Sonosurg System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation200515—
+1K030598Medisiss Reprocessed Ultrasonic Surgical InstrumentsMedisiss20040—
+1K031523Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd.200318—
+1K031305Olympus Ultrasonic Surgical SystemOlympus Optical Co., Ltd.200326—
+1K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd.200318—
+1K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co.200319—
+1K021929Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical SystemAxya Medical, Inc.20020—
+1K981993Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co.1998175—
+2K121550Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC201222
+2K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+2K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+2K050209Smith & Nephew Control Digital Operating Room SystemSmith & Nephew, Inc.20053—
+2K050829Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20053—
+2K042160Sonosurg TrocarAomori Olympus Co., Ltd.20050—
+2K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd.20040—
+2K032066Sonosurg SystemThe Olympus Optical Co.20031—
+2K020255Riwo Net Operating Operating Control System, Model #5590Richard Wolf Medical Instruments Corp.20021—
+2K022270Modification to Olympus Integrated Endosurgery System EndoalphaOlympus Optical Co., Ltd.20028—
+2K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp.2000157—
+3K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+3K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+3K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…Sterilmed, Inc.20160—
+3K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+3K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp.20160—
+3K132566Reprocessed Harmonic ShearSterilmed, Inc.20140—
+3K132703ThunderbeatOlympus Medical Systems Corp.20149—
+3K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+3K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+3K070556Brainsuite NetBrainlab AG20072—
+3K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20061—
+3K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc.200615429
+3K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20052—
+3K041494Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2)…Olympus Corporation20046—
+3K031979Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis)20030—
+4K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+4K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+4K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+4K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+4K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+4K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+4K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+4K170908PK AIMGyrus Acmi, Inc.20170—
+4K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+4K161122Sony IP Converter NU-IP40SSony Electronics, Inc.20161—
+4K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+4K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+4K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+4K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis)20090—
+4K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+4K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+4K051613Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Olympus Medical Systems Corporation20055—
+5K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+5K191678IP ConverterSony Electronics, Inc.20200—
+5K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+5K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+5K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+5K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+5K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications20102—
+5K100345Systems Integration Model: EndoalphaOlympus Medical Systems Corporation20101—
+5K091166IMRXImris, Inc.20091—
+5K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+5K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+5K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+5K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+6K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+6K223060DigiX FDXAllengers Medical Systems Limited20224—
+6K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+6K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+6K192541DigiX FDXAllengers Medical Systems Limited20195—
+6K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+6K162529DigiX FDXAllengers Medical Systems Limited20176—
+6K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+6K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+6K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+6K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+6K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+6K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+6K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+6K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd.20131—
+6K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+6K121513Multix FusionSiemens Medical Solution2012324
+6K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+6K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+6K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+6K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+6K102763Systems IntegrationOlympus Medical Systems Corporation20110—
+6K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+6K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+6K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+6K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+6K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+6K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+7K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+7K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+7K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+7K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+7K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+7K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—