510(k) Report

Devices descending from K070894

17 later devices reach Tephaflex Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143380Phasix ST MeshC.R. Bard, Inc.20154—
+1K142818Phasix MeshC. R. Bard20153—
+1K140533Galaflex MeshTepha, Inc.20143—
+1K120728Phasix Plug and PatchC.R. Bard, Inc.20120—
+1K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+1K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+1K093799Tornier Surgical MeshTornier, Inc.20102—
+2K202425SurgiLattice scaffoldTepha, Inc.20210—
+2K173143Phasix ST MeshC.R. Bard, Inc.20181—
+2K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+2K162922GalaFORM 3DTepha, Inc.20170—
+2K161424Phasix MeshC.R. Bard, Inc.20162—
+2K161092GalaSHAPE 3DTepha, Inc.201611
+3K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+3K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB20201—
+3K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+4K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production20240—