510(k) Report

Devices descending from K160176

5 later devices reach Signia Stapler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202864Tri-Staple 2.0 ReloadsCovidien20201—
+1K201672Signia Stapler (with new software)Covidien20200—
+1K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+1K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+2K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—