510(k) Report

Devices descending from K040998

61 later devices reach Modification to Parietex Composite (Pco) Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Sofradim Production201842
+1K130428CovameshBiomup S.A.20130—
+1K131969Symbotex (TM) Composite MeshSofradim Production201310—
+1K120506Parietex Composite Ventral PatchSofradim Production201211—
+1K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+1K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production201112—
+1K110816Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production201114—
+1K110815Parietex Optimized Compostie MeshSofradim Production20115—
+1K072974Surgimesh XBAspide Medical200832
+1K081126Parietex Composite Mono PM MeshSofradim Production2008151
+1K073287Prevadh MeshSofradim Production200817—
+1K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+1K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production200531—
+2K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+2K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+2K141721Bovine Pericardium PatchCollafirm, LLC20140—
+2K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production201451
+2K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+2K130997NeoveilGunze Limited20133—
+2K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+2K120025Surgimesh XB - SkirtedAspide Medical20120—
+2K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+2K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+2K101519Parietex Plug and PatchSofradim Production20106—
+2K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+2K090858Parietex Monofilament Polyester MeshSofradim Production200914—
+2K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+2K081050Parietex Progrip MeshSofradim Production200815—
+2K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+3K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+3K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+3K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+3K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+3K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+3K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+3K150091Versatex Monofilament MeshSofradim Production201542
+3K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production20145—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+3K112567Biomerix AssureBiomerix Corporation20110—
+3K103682Parietex ProgripSofradim Production20116—
+3K101197Parie Tene Progrip MeshSofradim Production20106—
+4K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+4K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+4K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+4K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+4K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+4K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+4K143386Progrip Laparoscopic Self-Fixating MeshSofradim Production20150—
+4K140941Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet MeshSofradim Production20145—
+5K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—
+5K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production20250—
+5K220540ProGrip Self-Gripping Polypropylene MeshCovidien20220—
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K142091Parietene Macroporous MeshSofradim Production20142—
+6K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production20250—
+6K223218Parietene Macroporous MeshSofradim Production20221—
+6K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+7K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—