510(k) Report

Devices descending from K022044

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+1K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+2K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+2K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+3K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+4K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—