510(k) Report

Devices descending from K923657

414 later devices reach Supple Peri-Guard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170016Biodesign Fistula PlugCook Biotech Incorporated20175—
+4K170951CardioCel 3DAdmedus Regen Pty, Ltd.20170—
+4K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+4K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+4K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+4K162741AxoGuard Nerve ConnectorCook Biotech Incorporated20162—
+4K162579VascuCelAdmedus Regen Pty, Ltd.20161—
+4K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+4K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+4K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+4K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+4K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+4K150341Miromatrix Biological Mesh RSMiromatrix Medical, Inc.20151—
+4K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+4K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+4K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+4K132660Nerve CuffCook Biotech Incorporated20146—
+4K130997NeoveilGunze Limited20133—
+4K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.20130—
+4K131658Gore Seamguard ReinforcementW. L. Gore & Associates, Inc.20131—
+4K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+4K130006Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated20130—
+4K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K120605Permacol Surgical ImplantCovidien, LLC20124—
+4K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K102307Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd.20110—
+4K101961Tigerpaw SystemLaax, Inc.20102—
+4K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+4K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+4K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+4K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+4K092926Acell Matristem Wound SheetAcell, Inc.200914—
+4K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc.20091—
+4K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+4K083307Synthasome X-RepairSynthasome, Inc.20099—
+4K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+4K082682Surgisis Biodesign Enterocutaneous Fistula PlugCook Biotech, Inc.20091—
+4K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+4K080442Seriscaffold Surgical MeshSerica Technologies, Inc.2008141
+4K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+4K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+4K081882Modification to Xylos Surgical MeshXylos Corporation200811—
+4K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP20084824
+4K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+4K071986LTM-RC Surgical MeshLifecell Corp.20073—
+4K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+4K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+4K0709184DDOMECousin Biotech20070—
+4K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+4K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+4K070560LRTM Surgical MeshLifecell Corp.2007502
+4K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+4K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+4K062729Surgisis RVP Recto-Vaginal Fistula PlugCook Biotech, Inc.2006012
+4K061474Collawound DressingCollamatrix Co., Inc.20063—
+4K060888Acell Powder Wound DressingAcell, Inc.20065—
+4K060829CosmatrixTei Biosciences, Inc.200618—
+4K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+4K053200Gore Seamguard Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200511
+4K053202Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW.L. Gore & Associates20050—
+4K051766OrthomendTei Biosciences, Inc.200535—
+4K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+4K051190Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20051—
+4K050355Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Tissue Science Laboratories, Plc200554—
+4K041669Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations200448
+4K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+4K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.200238—
+4K020654Stratasis Sling KitCook Biotech, Inc.20020—
+5K261543Phasix ST Parastomal Hernia MeshDavol, Inc., A Subsidiary of C.R. Bard, Inc.20260—
+5K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+5K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+5K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+5K243843Tendon Protect (50242)Kerecis Limited20250—
+5K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+5K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+5K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+5K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.20230—
+5K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+5K223074CorNeat EverPatchCorneat Vision, Ltd.202303
+5K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20232—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC20221—
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+5K210665Nerve TapeBiocircuit Technologies, Incorporated20221—
+5K202234NervAlign Nerve CuffRenerve, Ltd.20220—
+5K203267The BioBrace ImplantBiorez, Inc.20214—
+5K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+5K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+5K192112FlexBand PlusInternational Life Sciences20199—
+5K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+5K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+5K172593XCelliStem Wound PowderStemsys20181—
+5K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+5K171231Endoform Topical MatrixAroa Biosurgery20173—