510(k) Report

Devices descending from K132025

6 later devices reach Meso Bilayer Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+2K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+2K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+2K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+3K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+3K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—