510(k) Report

Devices descending from K992189

41 later devices reach Gore-Tex Dualmesh Biomaterial through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170134Reperen Surgical MeshIconlab, Inc.20170—
+1K120025Surgimesh XB - SkirtedAspide Medical20120—
+1K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+1K081069Gore Infinit MeshW. L. Gore & Associates, Inc.200821—
+1K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+2K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+2K141721Bovine Pericardium PatchCollafirm, LLC20140—
+2K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+2K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+2K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+2K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+2K083102Refine Lift SystemAlure Medical, Inc.20091—
+2K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+2K081777Ventrio Hernia PatchC.R. Bard, Inc.2008144
+2K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+3K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+3K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+3K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+3K142706Modified ONFLEX MeshC.R. Bard, Inc.20150—
+3K142711ONFLEX MeshC.R. Bard, Inc.20151—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K132441Bard Ventralex Hernia PatchC.R. Bard, Inc.20130—
+3K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+3K112567Biomerix AssureBiomerix Corporation20110—
+3K101928Ventralex ST Hernia PatchC.R. Bard, Inc.201111
+3K101920Ventrio ST Hernia PatchC.R. Bard, Inc.20113—
+3K100229Ventrio Hernia PatchC.R. Bard, Inc.201013—
+3K092538Refine Support System, Model 100.0100Alure Medical, Inc.20100—
+4K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.20250—
+4K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.20250—
+4K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+4K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.20191—
+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—
+4K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+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—