510(k) Report

Devices descending from DEN060003

22 later devices reach Tephaflex Absorbable Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132348Tephaflex Braided SutureTepha, Inc.20130—
+1K122487Biofiber SytureTornier, Inc.20122—
+1K100876Aesculap Monomax Absorbable SutureAesculap, Inc.20100—
+1K070894Tephaflex Surgical MeshTepha, Inc.200717—
+2K143380Phasix ST MeshC.R. Bard, Inc.20154—
+2K142818Phasix MeshC. R. Bard20153—
+2K140533Galaflex MeshTepha, Inc.20143—
+2K130422Phantom Fiber Biofiber SutureTornier, Inc.201311
+2K120728Phasix Plug and PatchC.R. Bard, Inc.20120—
+2K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+2K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+2K093799Tornier Surgical MeshTornier, Inc.20102—
+3K202425SurgiLattice scaffoldTepha, Inc.20210—
+3K173143Phasix ST MeshC.R. Bard, Inc.20181—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+3K162922GalaFORM 3DTepha, Inc.20170—
+3K161424Phasix MeshC.R. Bard, Inc.20162—
+3K161092GalaSHAPE 3DTepha, Inc.201611
+4K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+4K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB20201—
+4K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production20240—