510(k) Report

Devices descending from K810428

119 later devices reach Vicryl through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191373VICRYL MeshETHICON, Inc.20191—
+1K123128Seri Surgical ScaffoldAllergan20135—
+1K083307Synthasome X-RepairSynthasome, Inc.20099—
+1K080442Seriscaffold Surgical MeshSerica Technologies, Inc.2008141
+1K073287Prevadh MeshSofradim Production200817—
+1K070894Tephaflex Surgical MeshTepha, Inc.200717—
+1K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation200517—
+1K040868Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp.200434—
+1K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+1K963619Gore-Tex Soft Tissue Patch,Mycromesha Biomaterial,Dualmesh Biomaterial,Dualmesh…W. L. Gore & Associates, Inc.19960—
+2K201143VICRYL MeshETHICON, Inc.20200—
+2K173143Phasix ST MeshC.R. Bard, Inc.20181—
+2K172545SERI ContourSofregen Medical, Inc.20170—
+2K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+2K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+2K143380Phasix ST MeshC.R. Bard, Inc.20154—
+2K142818Phasix MeshC. R. Bard20153—
+2K141394X-RepairSynthasome20140—
+2K141499X-RepairslSynthasome, Inc.20140—
+2K140533Galaflex MeshTepha, Inc.20143—
+2K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+2K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+2K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+2K120728Phasix Plug and PatchC.R. Bard, Inc.20120—
+2K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+2K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+2K101928Ventralex ST Hernia PatchC.R. Bard, Inc.201111
+2K101920Ventrio ST Hernia PatchC.R. Bard, Inc.20113—
+2K101851Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc.2010102
+2K093799Tornier Surgical MeshTornier, Inc.20102—
+2K090288Orthadapt PRPegasus Biologics, Inc.20097—
+2K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+2K081050Parietex Progrip MeshSofradim Production200815—
+2K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+2K0709184DDOMECousin Biotech20070—
+2K063739Sepramesh, Model 5959-1214Genzyme Corporation200716—
+2K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+3K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.20250—
+3K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+3K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+3K202425SurgiLattice scaffoldTepha, Inc.20210—
+3K203267The BioBrace ImplantBiorez, Inc.20214—
+3K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+3K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.20191—
+3K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+3K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+3K162922GalaFORM 3DTepha, Inc.20170—
+3K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+3K161424Phasix MeshC.R. Bard, Inc.20162—
+3K161092GalaSHAPE 3DTepha, Inc.201611
+3K141721Bovine Pericardium PatchCollafirm, LLC20140—
+3K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+3K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+3K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+3K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+3K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+3K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc.20115—
+3K103682Parietex ProgripSofradim Production20116—
+3K101519Parietex Plug and PatchSofradim Production20106—
+3K101197Parie Tene Progrip MeshSofradim Production20106—
+3K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+3K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+3K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+4K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+4K242187BioBrace®Conmed Corporation20241—
+4K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB20201—
+4K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+4K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+4K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+4K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc.20152—
+4K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production20145—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+4K140941Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet MeshSofradim Production20145—
+4K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc.2012415
+4K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production20250—
+5K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+5K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production20240—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K220540ProGrip Self-Gripping Polypropylene MeshCovidien20220—
+5K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+5K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+5K193583Restrata®Acera Surgical, Inc.202011
+5K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+5K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…C. R. Bard20171—
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—