510(k) Report

Devices descending from K801623

257 later devices reach Cavitron Ultrasonic Surg. Aspir. Cusa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP200529—
+1K050776Auss-6 Ultrasonic Surgical Aspirator SystemMisonix, Inc.200517—
+1K962952Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co.1996214—
+1K960374Ultracut 2000Ultralase Technologies, Inc.19960—
+2K181367Tenex Health TX System with the TXP MicroTipTenex Health, Inc.20181—
+2K141674Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation201401
+2K141668Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation201414—
+2K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc.20112—
+2K090864Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator SystemIntegra Radionics, Inc.20090—
+2K072904Sonoca 180/195 Wound Care SystemSoering GmbH20081—
+2K071669Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc.200717—
+2K070313Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator SystemMisonix, Inc.20078—
+2K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC200751
+2K062471Ultrasonic Surgical Aspirator System, Model FS 1000 RFMisonix, Inc.20066—
+2K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd.20040—
+2K032066Sonosurg SystemThe Olympus Optical Co.20031—
+2K972114Olympus Sonosurg SystemThe Olympus Optical Co.1998213—
+3K241700Tenex 2nd Generation SystemTrice Medical, Inc.20240—
+3K221763CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20220—
+3K202299Ultrasonic Surgical Aspirator SystemSmtp Technology Co., Ltd.20211—
+3K190160neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc.20191—
+3K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20191—
+3K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20181042
+3K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation2016112
+3K153743Piezosurgery PlusMectron S.P.A.20162—
+3K150682CUSA Excel+Integra Lifesciences Corp.20151—
+3K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140—
+3K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc.20130—
+3K111741Integra (TM) Cusa NXT (TM) Bone TipsIntegra Burlington Ma, Inc. (Formerly Integra Radi20111—
+3K102258Cusa NXT Extended Length TipIntegra Radionics, Inc.20112—
+3K091038AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC20090—
+3K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc.2008164
+3K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation200515—
+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—
+4K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH20250—
+4K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20240—
+4K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20230—
+4K212060neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc.20210—
+4K212750Ultrasonic Surgical Aspirator System, Model: XD880BSmtp Technology Co., Ltd.20210—
+4K200774CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20205—
+4K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…Bennett Jacoby, Dds, Ms, Inc.20200—
+4K172595CUSA Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20170—
+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
+4K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+4K050209Smith & Nephew Control Digital Operating Room SystemSmith & Nephew, Inc.20053—
+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—
+5K221835CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20220—
+5K221235neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc.20222—
+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—
+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—
+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—
+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—
+6K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+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
+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—
+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—
+7K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+7K191678IP ConverterSony Electronics, Inc.20200—
+7K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+7K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+7K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531