GOLNIT Non-aborbable PTFE Surgical Suture

GOLNIT Non-aborbable PTFE Surgical Suture is an FDA 510(k)-cleared medical device (K192088) manufactured by Antarma, LLC 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 September 3, 2019. Regulation: 8.