510(k) Report

Devices descending from K921251

304 later devices reach Cusa System 200C and 200T Ultrasonic Aspirator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212049Oclet TDS 1000Tendonova Corporation20220—
+6K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+6K190386KTA Adipose Treatment KitStemics S.A.S20190—
+6K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+6K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+6K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+6K170908PK AIMGyrus Acmi, Inc.20170—
+6K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+6K170449Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml…Millennium Medical Technologies, Inc.20170—
+6K161122Sony IP Converter NU-IP40SSony Electronics, Inc.20161—
+6K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+6K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+6K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+6K141713Smartgraft 200 SystemIngeneron, Inc.20140—
+6K141591Smartgraft 30 SystemIngeneron, Inc.20140—
+6K132815Puregraft 50 SystemCytori Therapeutics, Inc.20140—
+6K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC20130—
+6K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp.201271
+6K120328Origins Lipoharvesting SystemSound Surgical Technologies, LLC20122—
+6K120902GID 700The Gid Group, Inc.2012111
+6K113255Puregraft 850/Pure SystemCytori Therapeutics, Inc.20121—
+6K102117Tissu Trans Filtron Syringe FillShippert Medical Technologies Corp.20100—
+6K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis)20090—
+6K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+6K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+6K051613Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Olympus Medical Systems Corporation20055—
+7K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC20260—
+7K203800SyntrFuge SystemSyntr Health Technologies, Inc.20210—
+7K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+7K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell Corporation20200—
+7K191678IP ConverterSony Electronics, Inc.20200—
+7K190278AuraGen 123 Suction Lipoplasty System (A123)Auragen Aesthetics, LLC20190—
+7K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+7K172717Automatic Tissue Processing UnitBsl Co.20180—
+7K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+7K172714LipiVageGenesis Biosystems, Inc.20170—
+7K163647Revolve Envi 600 Advanced Adipose SystemLifecell Corporation20170—
+7K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+7K150156Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…Ranfac, Corp.20150—
+7K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC20151—
+7K142682The Lipogems SystemLipogems International Spa20146—
+7K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+7K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications20102—
+7K100345Systems Integration Model: EndoalphaOlympus Medical Systems Corporation20101—
+7K091166IMRXImris, Inc.20091—
+7K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+7K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+7K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+7K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+8K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+8K223060DigiX FDXAllengers Medical Systems Limited20224—
+8K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+8K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+8K192541DigiX FDXAllengers Medical Systems Limited20195—
+8K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+8K162529DigiX FDXAllengers Medical Systems Limited20176—
+8K161636Lipogems SystemLipogems International Spa20165—
+8K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+8K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+8K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+8K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+8K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+8K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+8K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+8K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd.20131—
+8K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+8K121513Multix FusionSiemens Medical Solution2012324
+8K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+8K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+8K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+8K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+8K102763Systems IntegrationOlympus Medical Systems Corporation20110—
+8K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+8K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+8K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+8K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+8K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+8K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+9K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+9K230985Planmeca VisoPlanmeca Oy20233—
+9K210528IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…Millennium Medical Technologies Inc (Dba Cellmyx)20220—
+9K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+9K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+9K182732JTL-250-01Jointechlabs, Inc.20190—
+9K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+9K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+9K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+9K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+9K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+9K171135Lipogems SystemLipogems International Spa20172—
+9K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+9K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+9K161019Uroview FDPausch Medical GmbH201621
+9K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+9K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+9K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+9K151737MedicVOD SystemOrpheus Medical, Ltd.20160—
+9K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+9K150663Diagnostic X-ray SystemOsko, Inc.20150—
+9K143281Ultimax-iToshibamedical Systems Corporation20150—