510(k) Report

Devices descending from K163217

5 later devices reach GORE BIO-A Tissue Reinforcement through their predicates, nearest generation first.

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