510(k) K252171

Barbed PDO Suture by Sutura Medical Technology, Inc. — Product Code NEW

K252171 is an FDA 510(k) premarket notification submitted by Sutura Medical Technology, Inc. for the device "Barbed PDO Suture". The FDA issued a decision of Substantially Equivalent on June 12, 2026. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840.