510(k) Report

Devices descending from K992556

170 later devices reach Permacol through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140495Leveen Standard Needle Electrode, Leveen Coaccess Needle ElectrodeBoston Scientific Corp20146—
+1K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+1K061445Surgimesh WNAspide Medical200752
+1K050355Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Tissue Science Laboratories, Plc200554—
+1K043366Permacol Surgical ImplantTissue Science Laboratories, Plc200474—
+1K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.200238—
+1K020455Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.200256—
+1K013625PermacolTissue Science Laboratories, Plc200295—
+2K162934Biodesign Parastomal Hernia Repair GraftCook Biotech Incorporated20171—
+2K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+2K150029Habib EUS RFAEmcision, Ltd.20155—
+2K120025Surgimesh XB - SkirtedAspide Medical20120—
+2K120605Permacol Surgical ImplantCovidien, LLC20124—
+2K112567Biomerix AssureBiomerix Corporation20110—
+2K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+2K092233Surgimesh XDAspide Medical20100—
+2K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+2K080442Seriscaffold Surgical MeshSerica Technologies, Inc.2008141
+2K072974Surgimesh XBAspide Medical200832
+2K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+2K071986LTM-RC Surgical MeshLifecell Corp.20073—
+2K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+2K063154Facial Reconstructive Mesh (FRM)Evera Medical, Inc.20070—
+2K070560LRTM Surgical MeshLifecell Corp.2007502
+2K060829CosmatrixTei Biosciences, Inc.200618—
+2K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.200515—
+2K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+2K051190Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20051—
+2K050246Sis Dermal Augmentation StrandCook Biotech, Inc.20054—
+2K034039Sis Plastic Surgery MatrixCook Biotech, Inc.200493—
+2K031188OrthomendTei Biosciences, Inc.200336—
+3K261543Phasix ST Parastomal Hernia MeshDavol, Inc., A Subsidiary of C.R. Bard, Inc.20260—
+3K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+3K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+3K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+3K191734MatriStem UBM Pericardial PatchAcell, Inc.20190—
+3K181249EUSRA RF ElectrodeStarmed Co., Ltd.20182—
+3K170990Active Needle Endoscopic Treatment (ANET) Electrosurgical ApplicatorSpiration, Inc.20170—
+3K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+3K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+3K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+3K161305Habib EUS RFAEmcision, Ltd.201612
+3K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+3K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+3K151083BioBridge Collagen MatrixFibralign Corporation20169—
+3K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+3K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+3K142326HP Tissue MatrixLifecell Corporation201411—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+3K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+3K140501Xenmatrix Surgical GraftC. R. Bard20140—
+3K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+3K123128Seri Surgical ScaffoldAllergan20135—
+3K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+3K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+3K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+3K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+3K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc.20110—
+3K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+3K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+3K093799Tornier Surgical MeshTornier, Inc.20102—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+3K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc.20091—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K083898SurgimendTei Biosciences, Inc.200993
+3K082103LTM Wound DressingLifecell Corp.20087—
+3K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+3K080353LTM-T Surgical MeshLifecell Corp.20084—
+3K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+3K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+3K060984Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20060—
+3K053622Surgisis Ocular GraftIop, Inc.20062—
+3K051766OrthomendTei Biosciences, Inc.200535—
+3K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+4K240932HybridTherm SystemErbe Elektromedizin GmbH20241—
+4K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+4K223074CorNeat EverPatchCorneat Vision, Ltd.202303
+4K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+4K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K211132ARISTE AB MeshAriste Medical, LLC20220—
+4K202430Kerecis ReconstructKerecis Limited20213—
+4K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+4K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+4K172545SERI ContourSofregen Medical, Inc.20170—
+4K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+4K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+4K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+4K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+4K162554Gentrix Surgical MatrixAcell, Inc.20162—
+4K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+4K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+4K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+4K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+4K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+4K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+4K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+4K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442