510(k) Report

Devices descending from K051048

3 later devices reach Surgisis Staple Line Reinforcement II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+2K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+3K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—