510(k) Report

Devices descending from K001789

210 later devices reach Seamguard Staple Line Reinforcement Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+9K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+9K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+10K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+10K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+11K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+11K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+11K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+12K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+12K232295LAA Exclusion SystemSyntheon, LLC20231—