510(k) K253879

MONOFIX PDO by Samyang Holdings Corporation — Product Code NEW

K253879 is an FDA 510(k) premarket notification submitted by Samyang Holdings Corporation for the device "MONOFIX PDO". The FDA issued a decision of Substantially Equivalent on August 25, 2026. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840.