510(k) Report

Devices descending from K083898

9 later devices reach Surgimend through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+1K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+1K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+1K123128Seri Surgical ScaffoldAllergan20135—
+2K172545SERI ContourSofregen Medical, Inc.20170—
+2K140533Galaflex MeshTepha, Inc.20143—
+3K202425SurgiLattice scaffoldTepha, Inc.20210—
+3K162922GalaFORM 3DTepha, Inc.20170—
+3K161092GalaSHAPE 3DTepha, Inc.201611