510(k) Report

Devices descending from K040415

24 later devices reach Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130997NeoveilGunze Limited20133—
+1K101961Tigerpaw SystemLaax, Inc.20102—
+1K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+1K041669Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations200448
+2K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+2K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+2K153364Kerecis SecureMeshKerecis Limited20160—
+2K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+2K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+2K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+2K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+2K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+2K111064Tigerpaw System IILaax, Inc.20111Class I
+2K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+2K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+3K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+3K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp.20190—
+3K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+3K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+3K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+4K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+6K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—