510(k) K212810

MONOFIX PGCL, knotless wound closure device by Samyang Holdings Corp., Ltd. — Product Code GAM

K212810 is an FDA 510(k) premarket notification submitted by Samyang Holdings Corp., Ltd. for the device "MONOFIX PGCL, knotless wound closure device". The FDA issued a decision of Substantially Equivalent on August 5, 2022. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493.