510(k) Report

Devices descending from K954665

205 later devices reach Glycar Staple Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K172545SERI ContourSofregen Medical, Inc.20170—
+8K140533Galaflex MeshTepha, Inc.20143—
+9K202425SurgiLattice scaffoldTepha, Inc.20210—
+9K162922GalaFORM 3DTepha, Inc.20170—
+9K161092GalaSHAPE 3DTepha, Inc.201611