510(k) K250977

Suture-TOOL System by Suturion AB — Product Code NEW

K250977 is an FDA 510(k) premarket notification submitted by Suturion AB for the device "Suture-TOOL System". The FDA issued a decision of Substantially Equivalent on April 28, 2025. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Suturion AB has at least 1 other 510(k) clearance on record.