Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh

About This 510(k) Submission

K220586 is an FDA 510(k) clearance for the Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Sofradim Production (Tr?voux, FR). The FDA issued a Cleared decision on June 22, 2022, 113 days after receiving the submission on March 1, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.