About This 510(k) Submission
K173796 is an FDA 510(k) clearance for the Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references), 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 March 9, 2018, 85 days after receiving the submission on December 14, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.