510(k) Report

Devices descending from K102325

9 later devices reach Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+2K160176Signia StaplerCovidien2016514
+2K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+2K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+3K202864Tri-Staple 2.0 ReloadsCovidien20201—
+3K201672Signia Stapler (with new software)Covidien20200—
+3K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+3K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+4K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—