510(k) Report

Devices descending from K081069

21 later devices reach Gore Infinit Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+1K083102Refine Lift SystemAlure Medical, Inc.20091—
+1K081777Ventrio Hernia PatchC.R. Bard, Inc.2008144
+2K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+2K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+2K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+2K142706Modified ONFLEX MeshC.R. Bard, Inc.20150—
+2K142711ONFLEX MeshC.R. Bard, Inc.20151—
+2K132441Bard Ventralex Hernia PatchC.R. Bard, Inc.20130—
+2K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+2K101928Ventralex ST Hernia PatchC.R. Bard, Inc.201111
+2K101920Ventrio ST Hernia PatchC.R. Bard, Inc.20113—
+2K100229Ventrio Hernia PatchC.R. Bard, Inc.201013—
+2K092538Refine Support System, Model 100.0100Alure Medical, Inc.20100—
+3K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.20250—
+3K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.20250—
+3K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.20191—
+3K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+4K151177XenMatrix AB Surgical GraftC. R. Bard20151—