510(k) Report

Devices descending from K052415

15 later devices reach Power Linear Cutter Reusable Digital Loading Units with Reloads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063746Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc.200713—
+1K063075Natural Orifice Linear Cutter Digital Loading UnitsPower Medical Interventions, Inc.20060—
+2K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc.2007111
+2K073148Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc.20071—
+3K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca20109—
+3K091215Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent…Power Medical Interventions, Inc.200901
+4K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+5K160176Signia StaplerCovidien2016514
+5K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+5K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+6K202864Tri-Staple 2.0 ReloadsCovidien20201—
+6K201672Signia Stapler (with new software)Covidien20200—
+6K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+6K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+7K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—