510(k) Report

Devices descending from K951546

111 later devices reach Endopath and Proximate Linear Cutters and Staplers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K202864Tri-Staple 2.0 ReloadsCovidien20201—
+11K201672Signia Stapler (with new software)Covidien20200—
+11K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+11K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+11K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+12K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+13K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+13K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+13K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+14K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+14K232295LAA Exclusion SystemSyntheon, LLC20231—