510(k) Report

Devices descending from K010228

4 later devices reach Gore-Tex Dualmesh Plus Biomaterial with Holes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072974Surgimesh XBAspide Medical200832
+2K120025Surgimesh XB - SkirtedAspide Medical20120—
+2K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+3K112567Biomerix AssureBiomerix Corporation20110—