510(k) Report

Devices descending from K934628

90 later devices reach Cusa (R) Syst 200CT/200T Ultra Aspir Lap/Cem Access through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981262Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc.1998893
+2K141674Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation201401
+2K141668Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation201414—
+2K102258Cusa NXT Extended Length TipIntegra Radionics, Inc.20112—
+2K090864Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator SystemIntegra Radionics, Inc.20090—
+2K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP200529—
+2K042277Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd.200417—
+2K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd.20040—
+2K032066Sonosurg SystemThe Olympus Optical Co.20031—
+2K021989Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences2002232
+2K993628Omnisonics Ultrasonic ProbesOmnisonics Medical Technologies19990—
+2K991791Sound Vaser SystemSound Surgical Technologies, LLC1999492
+3K221763CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20220—
+3K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20191—
+3K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20181042
+3K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation2016112
+3K150682CUSA Excel+Integra Lifesciences Corp.20151—
+3K111741Integra (TM) Cusa NXT (TM) Bone TipsIntegra Burlington Ma, Inc. (Formerly Integra Radi20111—
+3K101561TX1 Tissue Removal SystemAmerican Optisurgical, Inc.201032
+3K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc.2008164
+3K071669Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc.200717—
+3K062471Ultrasonic Surgical Aspirator System, Model FS 1000 RFMisonix, Inc.20066—
+3K022051Soundvaser SystemSound Surgical Technologies, LLC2002482
+4K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20250—
+4K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20240—
+4K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20230—
+4K202299Ultrasonic Surgical Aspirator SystemSmtp Technology Co., Ltd.20211—
+4K200774CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20205—
+4K190160neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc.20191—
+4K181367Tenex Health TX System with the TXP MicroTipTenex Health, Inc.20181—
+4K172595CUSA Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20170—
+4K123640TX1 Tissue Removal SystemTenex Health201321
+4K113128Microaire Surgical Instruments LLCMicroaire Surgical Instruments, LLC201212
+4K113570Integra Cusa NXT Inferior Foward Bone TipIntegra Burlington Ma, Inc.20120—
+4K110306Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC201151
+4K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc.200436—
+4K041058Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc.200441
+5K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation20251—
+5K241700Tenex 2nd Generation SystemTrice Medical, Inc.20240—
+5K221835CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20220—
+5K221235neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc.20222—
+5K212060neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc.20210—
+5K212750Ultrasonic Surgical Aspirator System, Model: XD880BSmtp Technology Co., Ltd.20210—
+5K190551VASERlipo SystemSolta Medical20192—
+5K171242Alma LipoFlow SystemAlma Lasers, Inc.20170—
+5K153299Tenex Health TX SystemTenex Health, Inc.20161—
+5K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC20102—
+5K083455Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc.20095—
+5K072587Cytori Aft SystemCytori Therapeutics, Inc.200734—
+5K063235Cytori Lipoplasty System with Celase ReagentCytori Therapeutics, Inc.20070—
+5K052183Soring GMBH Sonoca LipoSoring GmbH Medizintechnik20053—
+6K254135LipoSurg ARTISTNouvag AG20260—
+6K212969LiposaverLhbiomed Co., Ltd.20241—
+6K231117neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company20231—
+6K212049Oclet TDS 1000Tendonova Corporation20220—
+6K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…Andrew Technologies, LLC20121—
+6K121703Lipokit with Disposable 50CC Aft SyringeMedi-Khan USA, Inc.20120—
+6K100114Fat Concentration SystemBiomet, Inc.20108—
+6K101713Lipcollector IIHuman Med AG20103—
+6K092923Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc.20102—
+6K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp.2009178
+6K081848Lipose Fat Transfer SystemLipose Corp.200812—
+7K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC20260—
+7K252495Lssa (NP-200)Newpong Co., Ltd.20260—
+7K190386KTA Adipose Treatment KitStemics S.A.S20190—
+7K170449Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml…Millennium Medical Technologies, Inc.20170—
+7K141713Smartgraft 200 SystemIngeneron, Inc.20140—
+7K141591Smartgraft 30 SystemIngeneron, Inc.20140—
+7K132815Puregraft 50 SystemCytori Therapeutics, Inc.20140—
+7K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC20130—
+7K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp.201271
+7K120328Origins Lipoharvesting SystemSound Surgical Technologies, LLC20122—
+7K120902GID 700The Gid Group, Inc.2012111
+7K113255Puregraft 850/Pure SystemCytori Therapeutics, Inc.20121—
+7K102117Tissu Trans Filtron Syringe FillShippert Medical Technologies Corp.20100—
+8K203800SyntrFuge SystemSyntr Health Technologies, Inc.20210—
+8K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell Corporation20200—
+8K190278AuraGen 123 Suction Lipoplasty System (A123)Auragen Aesthetics, LLC20190—
+8K172717Automatic Tissue Processing UnitBsl Co.20180—
+8K172714LipiVageGenesis Biosystems, Inc.20170—
+8K163647Revolve Envi 600 Advanced Adipose SystemLifecell Corporation20170—
+8K150156Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…Ranfac, Corp.20150—
+8K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC20151—
+8K142682The Lipogems SystemLipogems International Spa20146—
+9K161636Lipogems SystemLipogems International Spa20165—
+10K210528IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…Millennium Medical Technologies Inc (Dba Cellmyx)20220—
+10K182732JTL-250-01Jointechlabs, Inc.20190—
+10K171135Lipogems SystemLipogems International Spa20172—
+11K193363Dermapose RefreshPuregraft, LLC20201—
+12K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.20210—