510(k) Report

Devices descending from K930591

21 later devices reach TI-Cron and Dacron Sutures through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211792StitchKitOrigami Surgical Inc .20211—
+1K082535Covidien Sports Surgery as Meniscal Repair DeviceSurgical Devices, A Global Business Unit Covidien20080—
+1K081050Parietex Progrip MeshSofradim Production200815—
+1K060163Cardioflon, CardioxylPeters Surgical200602
+1K994000PolyesterTrading Consultants and Distributors Intl., Inc.20000—
+2K221527StitchKitOrigami Surgical Inc .20230—
+2K103682Parietex ProgripSofradim Production20116—
+2K101519Parietex Plug and PatchSofradim Production20106—
+2K101197Parie Tene Progrip MeshSofradim Production20106—
+3K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production20145—
+3K140941Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet MeshSofradim Production20145—
+4K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production20250—
+4K220540ProGrip Self-Gripping Polypropylene MeshCovidien20220—
+4K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+4K143386Progrip Laparoscopic Self-Fixating MeshSofradim Production20150—
+4K142091Parietene Macroporous MeshSofradim Production20142—
+5K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production20250—
+5K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+5K223218Parietene Macroporous MeshSofradim Production20221—
+6K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+7K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—