510(k) Report

Devices descending from K861153

35 later devices reach Disposable Syringes and Hypodermic Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072587Cytori Aft SystemCytori Therapeutics, Inc.200734—
+2K100114Fat Concentration SystemBiomet, Inc.20108—
+2K101713Lipcollector IIHuman Med AG20103—
+2K092923Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc.20102—
+2K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp.2009178
+2K083455Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc.20095—
+2K081848Lipose Fat Transfer SystemLipose Corp.200812—
+3K190386KTA Adipose Treatment KitStemics S.A.S20190—
+3K170449Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml…Millennium Medical Technologies, Inc.20170—
+3K141713Smartgraft 200 SystemIngeneron, Inc.20140—
+3K141591Smartgraft 30 SystemIngeneron, Inc.20140—
+3K132815Puregraft 50 SystemCytori Therapeutics, Inc.20140—
+3K121703Lipokit with Disposable 50CC Aft SyringeMedi-Khan USA, Inc.20120—
+3K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp.201271
+3K120328Origins Lipoharvesting SystemSound Surgical Technologies, LLC20122—
+3K120902GID 700The Gid Group, Inc.2012111
+3K113255Puregraft 850/Pure SystemCytori Therapeutics, Inc.20121—
+3K102117Tissu Trans Filtron Syringe FillShippert Medical Technologies Corp.20100—
+4K203800SyntrFuge SystemSyntr Health Technologies, Inc.20210—
+4K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell Corporation20200—
+4K190278AuraGen 123 Suction Lipoplasty System (A123)Auragen Aesthetics, LLC20190—
+4K172717Automatic Tissue Processing UnitBsl Co.20180—
+4K172714LipiVageGenesis Biosystems, Inc.20170—
+4K163647Revolve Envi 600 Advanced Adipose SystemLifecell Corporation20170—
+4K150156Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…Ranfac, Corp.20150—
+4K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC20151—
+4K142682The Lipogems SystemLipogems International Spa20146—
+4K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC20130—
+5K171242Alma LipoFlow SystemAlma Lasers, Inc.20170—
+5K161636Lipogems SystemLipogems International Spa20165—
+6K210528IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…Millennium Medical Technologies Inc (Dba Cellmyx)20220—
+6K182732JTL-250-01Jointechlabs, Inc.20190—
+6K171135Lipogems SystemLipogems International Spa20172—
+7K193363Dermapose RefreshPuregraft, LLC20201—
+8K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.20210—