510(k) K180829

PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh by ETHICON, Inc. — Product Code FTL

K180829 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh". The FDA issued a decision of Substantially Equivalent on Jun 28, 2018. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. ETHICON, Inc. has 207 other 510(k) clearances on record.