510(k) Report

Devices descending from K040868

34 later devices reach Sepramesh IP Bioresorbable Barrier - Permanent Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101928Ventralex ST Hernia PatchC.R. Bard, Inc.201111
+1K101920Ventrio ST Hernia PatchC.R. Bard, Inc.20113—
+1K101851Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc.2010102
+1K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+1K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation200517—
+2K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.20250—
+2K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.20191—
+2K143380Phasix ST MeshC.R. Bard, Inc.20154—
+2K141721Bovine Pericardium PatchCollafirm, LLC20140—
+2K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+2K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+2K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+2K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc.20115—
+2K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+2K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+2K063739Sepramesh, Model 5959-1214Genzyme Corporation200716—
+3K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+3K173143Phasix ST MeshC.R. Bard, Inc.20181—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+3K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc.20152—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc.2012415
+4K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+4K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+4K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+4K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…C. R. Bard20171—
+4K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+4K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+4K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc.201334
+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—