510(k) Report

Devices descending from K003990

16 later devices reach Sofradim Parietex Surgical Meshes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101197Parie Tene Progrip MeshSofradim Production20106—
+1K081050Parietex Progrip MeshSofradim Production200815—
+2K140941Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet MeshSofradim Production20145—
+2K103682Parietex ProgripSofradim Production20116—
+2K101519Parietex Plug and PatchSofradim Production20106—
+3K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production20250—
+3K220540ProGrip Self-Gripping Polypropylene MeshCovidien20220—
+3K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production20145—
+3K142091Parietene Macroporous MeshSofradim Production20142—
+4K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production20250—
+4K223218Parietene Macroporous MeshSofradim Production20221—
+4K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+4K143386Progrip Laparoscopic Self-Fixating MeshSofradim Production20150—
+5K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+6K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+7K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—