510(k) Report

Devices descending from K983162

336 later devices reach Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+6K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+6K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+6K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+6K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+6K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+6K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+6K150551GORE SEAMGUARD ReinforcementW. L. Gore & Associates, Inc.20150—
+6K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+6K140501Xenmatrix Surgical GraftC. R. Bard20140—
+6K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+6K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+6K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+6K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+6K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+6K070644Gore Seamguard Staple Line Reinforcement Material for Circular StaplersW. L. Gore & Associates, Inc.20070—
+7K260218LacertaMatrixLacerta Life Sciences20260—
+7K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC20260—
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—
+7K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+7K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+7K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+7K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+7K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+8K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+9K180010AtriClip FLEX-VAtriCure, Inc.20188—
+10K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+11K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+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—