510(k) Report

Devices descending from K843034

132 later devices reach Disposable Linear Cutter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K073148Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc.20071—
+6K063746Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc.200713—
+6K063075Natural Orifice Linear Cutter Digital Loading UnitsPower Medical Interventions, Inc.20060—
+7K221006GIA Stapler with Tri-Staple TechnologyCovidien20221—
+7K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.20210—
+7K202701GIA Stapler with Tri-Staple TechnologyCovidien20202—
+7K202864Tri-Staple 2.0 ReloadsCovidien20201—
+7K201672Signia Stapler (with new software)Covidien20200—
+7K182380AEON Endoscopic StaplerLexington Medical, Inc.20184—
+7K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+7K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+7K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+7K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren20170—
+7K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+7K143562Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc.20150—
+7K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit)Ezisurg Medical Co., Ltd.20150—
+7K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H20143—
+8K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+8K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+8K201882AEON Endoscopic StaplerLexington Medical, Inc.20203—
+8K180010AtriClip FLEX-VAtriCure, Inc.20188—
+9K222210AEON Endoscopic StaplerLexington Medical, Inc.20232—
+9K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+10K251482AEON™ Endoscopic Powered StaplerLexington Medical, Inc.20250—
+10K234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler…Lexington Medical, Inc.20240—
+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—