510(k) K212888

Golnit Nylon Monofilament Suture by Antarma, LLC Dba Golnit Sutures — Product Code GAR

K212888 is an FDA 510(k) premarket notification submitted by Antarma, LLC Dba Golnit Sutures for the device "Golnit Nylon Monofilament Suture". The FDA issued a decision of Substantially Equivalent on March 31, 2022. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Antarma, LLC Dba Golnit Sutures has at least 1 other 510(k) clearance on record.