510(k) K223218

Parietene Macroporous Mesh by Sofradim Production — Product Code FTL

K223218 is an FDA 510(k) premarket notification submitted by Sofradim Production for the device "Parietene Macroporous Mesh". The FDA issued a decision of Substantially Equivalent on December 2, 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.