About This 510(k) Submission
K192088 is an FDA 510(k) clearance for the GOLNIT Non-aborbable PTFE Surgical Suture, a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II — Special Controls, product code NBY), submitted by Antarma, LLC Dba Golnit Sutures (New York, US). The FDA issued a Cleared decision on September 4, 2019, 30 days after receiving the submission on August 5, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5035.