510(k) Report

Devices descending from K021249

22 later devices reach Surgassist Flexshaft 2, Model FS2 14 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc.2007211
+2K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Covidien, Formerly Valleylab, A Division of Tyco20115—
+2K091215Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent…Power Medical Interventions, Inc.200901
+2K083527Intelligent Articulating Endoscopic Linear Cutter Reverse with ReloadsPower Medical Interventions, Inc.200801
+2K081826Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads…Power Medical Interventions, Inc.200801
+2K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc.2007111
+2K073148Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc.20071—
+3K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+3K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren20170—
+3K143562Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc.20150—
+3K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H20143—
+3K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca20109—
+4K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+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—