FDA Product Code GAT: Suture, Nonabsorbable, Synthetic, Polyethylene
Under FDA product code GAT, nonabsorbable synthetic polyethylene sutures are cleared for use in soft tissue approximation and ligation.
These sutures are made from ultra-high molecular weight polyethylene or other synthetic polymers that do not degrade in tissue. Their high tensile strength and low elongation make them particularly suited for orthopedic procedures including tendon repair, ligament reconstruction, and cerclage fixation.
GAT devices are Class II medical devices, regulated under 21 CFR 878.5000 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Arthrex, Inc., Riverpoint Medical and Medos International SARL.
List of Suture, Nonabsorbable, Synthetic, Polyethylene devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Suture, Nonabsorbable, Synthetic, Polyethylene devices (product code GAT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →