PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh

About This 510(k) Submission

K180829 is an FDA 510(k) clearance for the PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on June 28, 2018, 90 days after receiving the submission on March 30, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.