FDA Product Code FTL: Mesh, Surgical, Polymeric
Surgical mesh has transformed the repair of abdominal wall defects. FDA product code FTL covers polymeric surgical mesh used for tissue reinforcement and repair.
These woven or knitted synthetic materials — typically polypropylene or polyester — provide structural support to weakened or deficient tissue in hernia repair, pelvic floor reconstruction, and other procedures where native tissue alone is insufficient for durable closure.
FTL devices are Class II medical devices, regulated under 21 CFR 878.3300 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Sofradim Production, Davol Inc., Subsidiary of C. R. Bard, Inc. and Davol, Inc..
FDA 510(k) Cleared Mesh, Surgical, Polymeric Devices (Product Code FTL)
About Product Code FTL - Regulatory Context
510(k) Submission Activity
335 total 510(k) submissions under product code FTL since 1979, with 335 receiving FDA clearance (average review time: 118 days).
Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
Recent submissions under FTL have taken an average of 46 days to reach a decision - down from 120 days historically, suggesting improved FDA processing for this classification.
FTL devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →