510(k) Report

Devices descending from K923657

414 later devices reach Supple Peri-Guard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232847SiOxD Wound MatrixSioxmed, LLC20231—
+8K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+8K202864Tri-Staple 2.0 ReloadsCovidien20201—
+8K201672Signia Stapler (with new software)Covidien20200—
+8K180010AtriClip FLEX-VAtriCure, Inc.20188—
+8K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+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—