510(k) Report

Devices descending from K002699

123 later devices reach Parietex Composite (Pco) Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+5K143386Progrip Laparoscopic Self-Fixating MeshSofradim Production20150—
+5K140941Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet MeshSofradim Production20145—
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+5K090778Mta Protective SheetXylos Corporation20092—
+5K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+6K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—
+6K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production20250—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K220540ProGrip Self-Gripping Polypropylene MeshCovidien20220—
+6K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+6K142091Parietene Macroporous MeshSofradim Production20142—
+6K100984Xylos Vessel GuardXylos Corporation20100—
+7K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production20250—
+7K223218Parietene Macroporous MeshSofradim Production20221—
+7K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—