510(k) Report

Devices descending from K010936

11 later devices reach Modification to Seamguard Staple Line Reinforcement Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021477Preclude MVP Dura SubstituteW. L. Gore & Associates, Inc.20023—
+1K022044Surgisis Staple Line ReinforcementCook Biotech, Inc.20026—
+2K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+2K113071Synthecel Dura Replacement DevicesSynthes201225
+2K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+3K212943SyntheCel Dura RepairSynthes (USA) Products, LLC20220—
+3K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+3K131792Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc.201315
+3K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+4K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+5K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—