510(k) K220586

Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh by Sofradim Production — Product Code FTL

K220586 is an FDA 510(k) premarket notification submitted by Sofradim Production for the device "Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh". The FDA issued a decision of Substantially Equivalent on June 22, 2022. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Sofradim Production has at least 10 other 510(k) clearances on record.