GOLNIT Non-Absorbable PTFE Surgical Suture

GOLNIT Non-Absorbable PTFE Surgical Suture is an FDA 510(k)-cleared medical device (K163049) manufactured by Antarma Dba Golnit Sutures. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2017. Regulation: 8.