510(k) Report

Devices descending from K003323

44 later devices reach Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061314Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc.200615—
+1K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production200531—
+2K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Sofradim Production201842
+2K110816Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production201114—
+2K081777Ventrio Hernia PatchC.R. Bard, Inc.2008144
+2K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+3K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+3K142706Modified ONFLEX MeshC.R. Bard, Inc.20150—
+3K142711ONFLEX MeshC.R. Bard, Inc.20151—
+3K141721Bovine Pericardium PatchCollafirm, LLC20140—
+3K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+3K132441Bard Ventralex Hernia PatchC.R. Bard, Inc.20130—
+3K131969Symbotex (TM) Composite MeshSofradim Production201310—
+3K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+3K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+3K120025Surgimesh XB - SkirtedAspide Medical20120—
+3K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+3K101928Ventralex ST Hernia PatchC.R. Bard, Inc.201111
+3K101920Ventrio ST Hernia PatchC.R. Bard, Inc.20113—
+3K100229Ventrio Hernia PatchC.R. Bard, Inc.201013—
+3K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+3K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+4K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.20250—
+4K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.20250—
+4K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+4K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+4K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.20191—
+4K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production201451
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+4K130997NeoveilGunze Limited20133—
+5K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+5K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+5K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+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—
+5K150091Versatex Monofilament MeshSofradim Production201542
+5K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+6K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—
+6K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+6K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+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—