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., Threadstone, LLC and Riverpoint Medical.
FDA 510(k) Cleared Suture, Nonabsorbable, Synthetic, Polyethylene Devices (Product Code GAT)
About Product Code GAT - Regulatory Context
510(k) Submission Activity
173 total 510(k) submissions under product code GAT since 1993, with 173 receiving FDA clearance (average review time: 128 days).
Submission volume has declined in recent years - 8 submissions in the last 24 months compared to 13 in the prior period.
FDA Review Time
Recent submissions under GAT have taken an average of 77 days to reach a decision - down from 131 days historically, suggesting improved FDA processing for this classification.
GAT devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →