510(k) Report

Devices descending from K094061

10 later devices reach Kensey Nash Ecm Surgical Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+1K103787Medeor MatrixKensey Nash Corp.20112—
+2K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+2K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+2K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+3K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+3K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+4K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—