510(k) Report

Devices descending from K991400

82 later devices reach Parietene Polypropylene Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140941Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet MeshSofradim Production20145—
+1K101197Parie Tene Progrip MeshSofradim Production20106—
+1K073579Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNNFeg Textiltechnik Forschungs-Und Entwicklungsgesel20083—
+1K073164Ivs Tunneller DevicesCovidien UK Manufacturing, Ltd.20080—
+1K072951Parietene Duo and Quadra Polypropylene MeshesSofradim Production20070—
+1K041176Uretex to Trans-Obturator Urethral Support SystemSofradim Production20044—
+1K033376Ugytex MeshSofradim Production200470—
+1K012949Uretex Sup Pubourethral SlingSofradim Production20010—
+2K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production20250—
+2K220540ProGrip Self-Gripping Polypropylene MeshCovidien20220—
+2K142091Parietene Macroporous MeshSofradim Production20142—
+2K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel20132—
+2K073287Prevadh MeshSofradim Production200817—
+2K070073Align Urethral Support SystemC.R. Bard, Inc.20071—
+2K051533I-STOPCl Medical20051—
+2K051503Ugytex Sual Knit MeshSofradim Production200512—
+2K040998Modification to Parietex Composite (Pco) MeshSofradim Production200461—
+3K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production20250—
+3K223218Parietene Macroporous MeshSofradim Production20221—
+3K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Sofradim Production201842
+3K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft20161—
+3K130428CovameshBiomup S.A.20130—
+3K131969Symbotex (TM) Composite MeshSofradim Production201310—
+3K120506Parietex Composite Ventral PatchSofradim Production201211—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+3K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production201112—
+3K110816Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production201114—
+3K110815Parietex Optimized Compostie MeshSofradim Production20115—
+3K093747Align and Align to Urethral Support SystemsC.R. Bard, Inc.20100—
+3K072974Surgimesh XBAspide Medical200832
+3K081126Parietex Composite Mono PM MeshSofradim Production2008151
+3K081050Parietex Progrip MeshSofradim Production200815—
+3K063712Avaulta Support System/Avaulta Plus Biosynthetic Support SystemC.R. Bard, Inc.200710—
+3K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+3K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+3K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production200531—
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+4K182087DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft20180—
+4K141721Bovine Pericardium PatchCollafirm, LLC20140—
+4K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production201451
+4K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+4K130997NeoveilGunze Limited20133—
+4K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+4K120025Surgimesh XB - SkirtedAspide Medical20120—
+4K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+4K103682Parietex ProgripSofradim Production20116—
+4K101519Parietex Plug and PatchSofradim Production20106—
+4K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+4K090858Parietex Monofilament Polyester MeshSofradim Production200914—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K083839Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support SystemC.R. Bard, Inc.20090—
+4K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+4K082571Avaulta Support SystemC.R. Bard, Inc.20081—
+4K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+5K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+5K150091Versatex Monofilament MeshSofradim Production201542
+5K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production20145—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+5K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+6K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+6K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+6K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+6K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+6K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+6K143386Progrip Laparoscopic Self-Fixating MeshSofradim Production20150—
+7K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—
+7K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+8K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+9K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—