510(k) Report

Devices descending from K983316

84 later devices reach Ultracision 5MM Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993868The Soundvaser Dissection SystemSound Surgical Technologies, LLC1999492
+1K990362Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc.199933—
+2K151136Harmonic HookEthicon Endo-Surgery, LLC20161—
+2K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+2K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd.200318—
+2K022051Soundvaser SystemSound Surgical Technologies, LLC2002482
+3K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+3K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+3K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+3K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+3K113128Microaire Surgical Instruments LLCMicroaire Surgical Instruments, LLC201212
+3K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+3K110306Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC201151
+3K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation200515—
+3K042160Sonosurg TrocarAomori Olympus Co., Ltd.20050—
+3K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc.200436—
+3K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd.20040—
+3K041058Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc.200441
+4K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation20251—
+4K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+4K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+4K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+4K190551VASERlipo SystemSolta Medical20192—
+4K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+4K171242Alma LipoFlow SystemAlma Lasers, Inc.20170—
+4K170908PK AIMGyrus Acmi, Inc.20170—
+4K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+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—
+4K132703ThunderbeatOlympus Medical Systems Corp.20149—
+4K121550Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC201222
+4K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC20102—
+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—
+4K052183Soring GMBH Sonoca LipoSoring GmbH Medizintechnik20053—
+5K254135LipoSurg ARTISTNouvag AG20260—
+5K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+5K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+5K212969LiposaverLhbiomed Co., Ltd.20241—
+5K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+5K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+5K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+5K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+5K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+5K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+5K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…Sterilmed, Inc.20160—
+5K132566Reprocessed Harmonic ShearSterilmed, Inc.20140—
+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—
+6K252495Lssa (NP-200)Newpong Co., Ltd.20260—
+6K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+6K190386KTA Adipose Treatment KitStemics S.A.S20190—
+6K170449Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml…Millennium Medical Technologies, Inc.20170—
+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—
+7K203800SyntrFuge SystemSyntr Health Technologies, Inc.20210—
+7K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell Corporation20200—
+7K190278AuraGen 123 Suction Lipoplasty System (A123)Auragen Aesthetics, LLC20190—
+7K172717Automatic Tissue Processing UnitBsl Co.20180—
+7K172714LipiVageGenesis Biosystems, Inc.20170—
+7K163647Revolve Envi 600 Advanced Adipose SystemLifecell Corporation20170—
+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—
+8K161636Lipogems SystemLipogems International Spa20165—
+9K210528IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…Millennium Medical Technologies Inc (Dba Cellmyx)20220—
+9K182732JTL-250-01Jointechlabs, Inc.20190—
+9K171135Lipogems SystemLipogems International Spa20172—
+10K193363Dermapose RefreshPuregraft, LLC20201—
+11K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.20210—