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
+1K991791Sound Vaser SystemSound Surgical Technologies, LLC1999492
+1K981262Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc.1998893
+1K962952Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co.1996214—
+1K960040Sharplan Ultra Laparoscopic HandpieceSharplan Lasers, Inc.19960—
+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
+2K022051Soundvaser SystemSound Surgical Technologies, LLC2002482
+2K993628Omnisonics Ultrasonic ProbesOmnisonics Medical Technologies19990—
+2K972114Olympus Sonosurg SystemThe Olympus Optical Co.1998213—
+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—
+3K113128Microaire Surgical Instruments LLCMicroaire Surgical Instruments, LLC201212
+3K111741Integra (TM) Cusa NXT (TM) Bone TipsIntegra Burlington Ma, Inc. (Formerly Integra Radi20111—
+3K110306Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC201151
+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—
+3K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation200515—
+3K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc.200436—
+3K041058Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc.200441
+3K030598Medisiss Reprocessed Ultrasonic Surgical InstrumentsMedisiss20040—
+3K031523Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd.200318—
+3K031305Olympus Ultrasonic Surgical SystemOlympus Optical Co., Ltd.200326—
+3K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd.200318—
+3K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co.200319—
+3K021929Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical SystemAxya Medical, Inc.20020—
+3K981993Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co.1998175—
+4K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20250—
+4K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation20251—
+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—
+4K190551VASERlipo SystemSolta Medical20192—
+4K181367Tenex Health TX System with the TXP MicroTipTenex Health, Inc.20181—
+4K172595CUSA Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20170—
+4K171242Alma LipoFlow SystemAlma Lasers, Inc.20170—
+4K123640TX1 Tissue Removal SystemTenex Health201321
+4K121550Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC201222
+4K113570Integra Cusa NXT Inferior Foward Bone TipIntegra Burlington Ma, Inc.20120—
+4K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+4K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC20102—
+4K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+4K083455Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc.20095—
+4K072587Cytori Aft SystemCytori Therapeutics, Inc.200734—
+4K063235Cytori Lipoplasty System with Celase ReagentCytori Therapeutics, Inc.20070—
+4K050209Smith & Nephew Control Digital Operating Room SystemSmith & Nephew, Inc.20053—
+4K052183Soring GMBH Sonoca LipoSoring GmbH Medizintechnik20053—
+4K050829Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20053—
+4K042160Sonosurg TrocarAomori Olympus Co., Ltd.20050—
+4K020255Riwo Net Operating Operating Control System, Model #5590Richard Wolf Medical Instruments Corp.20021—
+4K022270Modification to Olympus Integrated Endosurgery System EndoalphaOlympus Optical Co., Ltd.20028—
+4K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp.2000157—
+5K254135LipoSurg ARTISTNouvag AG20260—
+5K241700Tenex 2nd Generation SystemTrice Medical, Inc.20240—
+5K212969LiposaverLhbiomed Co., Ltd.20241—
+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—
+5K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+5K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+5K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…Sterilmed, Inc.20160—
+5K153299Tenex Health TX SystemTenex Health, Inc.20161—
+5K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+5K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp.20160—
+5K132566Reprocessed Harmonic ShearSterilmed, Inc.20140—
+5K132703ThunderbeatOlympus Medical Systems Corp.20149—
+5K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+5K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+5K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…Andrew Technologies, LLC20121—
+5K121703Lipokit with Disposable 50CC Aft SyringeMedi-Khan USA, Inc.20120—
+5K100114Fat Concentration SystemBiomet, Inc.20108—
+5K101713Lipcollector IIHuman Med AG20103—
+5K092923Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc.20102—
+5K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp.2009178
+5K081848Lipose Fat Transfer SystemLipose Corp.200812—
+5K070556Brainsuite NetBrainlab AG20072—
+5K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20061—
+5K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc.200615429
+5K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20052—
+5K041494Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2)…Olympus Corporation20046—
+5K031979Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis)20030—
+6K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+6K252495Lssa (NP-200)Newpong Co., Ltd.20260—
+6K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+6K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+6K231117neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company20231—