510(k) Report

Devices descending from K110663

12 later devices reach Pairetex Optimized Composite Mesh (Pco-FX Refrences) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Sofradim Production201842
+1K131969Symbotex (TM) Composite MeshSofradim Production201310—
+2K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+2K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production201451
+2K130997NeoveilGunze Limited20133—
+3K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+3K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+3K150091Versatex Monofilament MeshSofradim Production201542
+3K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+4K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+4K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+5K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—