510(k) Report

Devices descending from K033376

70 later devices reach Ugytex Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073287Prevadh MeshSofradim Production200817—
+1K051503Ugytex Sual Knit MeshSofradim Production200512—
+1K040998Modification to Parietex Composite (Pco) MeshSofradim Production200461—
+2K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Sofradim Production201842
+2K130428CovameshBiomup S.A.20130—
+2K131969Symbotex (TM) Composite MeshSofradim Production201310—
+2K120506Parietex Composite Ventral PatchSofradim Production201211—
+2K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+2K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+2K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production201112—
+2K110816Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production201114—
+2K110815Parietex Optimized Compostie MeshSofradim Production20115—
+2K072974Surgimesh XBAspide Medical200832
+2K081126Parietex Composite Mono PM MeshSofradim Production2008151
+2K081050Parietex Progrip MeshSofradim Production200815—
+2K072951Parietene Duo and Quadra Polypropylene MeshesSofradim Production20070—
+2K063712Avaulta Support System/Avaulta Plus Biosynthetic Support SystemC.R. Bard, Inc.200710—
+2K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+2K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production200531—
+3K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+3K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+3K141721Bovine Pericardium PatchCollafirm, LLC20140—
+3K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production201451
+3K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+3K130997NeoveilGunze Limited20133—
+3K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+3K120025Surgimesh XB - SkirtedAspide Medical20120—
+3K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+3K103682Parietex ProgripSofradim Production20116—
+3K101519Parietex Plug and PatchSofradim Production20106—
+3K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+3K101197Parie Tene Progrip MeshSofradim Production20106—
+3K090858Parietex Monofilament Polyester MeshSofradim Production200914—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K083839Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support SystemC.R. Bard, Inc.20090—
+3K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+3K082571Avaulta Support SystemC.R. Bard, Inc.20081—
+3K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+4K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+4K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+4K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+4K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+4K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+4K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+4K150091Versatex Monofilament MeshSofradim Production201542
+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—
+4K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K112567Biomerix AssureBiomerix Corporation20110—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+5K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production20250—
+5K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+5K220540ProGrip Self-Gripping Polypropylene MeshCovidien20220—
+5K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+5K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+5K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K143386Progrip Laparoscopic Self-Fixating MeshSofradim Production20150—
+5K142091Parietene Macroporous MeshSofradim Production20142—
+6K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—
+6K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production20250—
+6K223218Parietene Macroporous MeshSofradim Production20221—
+6K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+7K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+8K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—