510(k) K143386

Progrip Laparoscopic Self-Fixating Mesh by Sofradim Production — Product Code FTL

K143386 is an FDA 510(k) premarket notification submitted by Sofradim Production for the device "Progrip Laparoscopic Self-Fixating Mesh". The FDA issued a decision of Substantially Equivalent on March 13, 2015. 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.