510(k) Report

Devices descending from K012809

66 later devices reach Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca20109—
+1K052910Power Right Angle Linear Cutter Digital Loading Unit with ReloadsPower Medical Interventions, Inc.20050—
+1K021701Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45 & RALC60Power Medical Interventions, Inc.200251
+1K021249Surgassist Flexshaft 2, Model FS2 14Power Medical Interventions, Inc.2002221
+1K020719Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and…Power Medical Interventions, Inc.2002471
+1K020343Surgassist System; Wireless Remote Control (Component); Wired Remote ControlPower Medical Interventions, Inc.2002131
+2K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+2K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc.2007211
+2K053510IR Wireless Foot SwitchLinemaster Switch Corp.2006122
+2K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc.2004251
+2K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc.200346—
+2K022313Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with Reloads…Power Medical Interventions, Inc.20023—
+3K191328Megadyne Foot SwitchMegadyne Medical Products, Inc.20190—
+3K160176Signia StaplerCovidien2016514
+3K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+3K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+3K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Covidien, Formerly Valleylab, A Division of Tyco20115—
+3K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company20108—
+3K091215Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent…Power Medical Interventions, Inc.200901
+3K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Conmed Linvatec20099—
+3K083527Intelligent Articulating Endoscopic Linear Cutter Reverse with ReloadsPower Medical Interventions, Inc.200801
+3K081826Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads…Power Medical Interventions, Inc.200801
+3K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc.2007111
+3K073148Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc.20071—
+3K062074Iridex Wireless FootswitchIridex Corp20060—
+3K052415Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc.2005151
+3K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc.200445—
+4K202864Tri-Staple 2.0 ReloadsCovidien20201—
+4K201672Signia Stapler (with new software)Covidien20200—
+4K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+4K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+4K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren20170—
+4K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+4K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+4K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+4K143562Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc.20150—
+4K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+4K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H20143—
+4K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+4K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120—
+4K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+4K063746Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc.200713—
+4K063075Natural Orifice Linear Cutter Digital Loading UnitsPower Medical Interventions, Inc.20060—
+5K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+5K231126Eblator DeviceE Surgical, LLC20231—
+5K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+5K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+5K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+5K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+5K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+5K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+5K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+6K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+6K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+6K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+6K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+7K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+8K180010AtriClip FLEX-VAtriCure, Inc.20188—
+9K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+10K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+11K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+12K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+12K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+12K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+13K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+13K232295LAA Exclusion SystemSyntheon, LLC20231—