510(k) K250659

LoFric Origo by Wellspect AB — Product Code EZD

K250659 is an FDA 510(k) premarket notification submitted by Wellspect AB for the device "LoFric Origo". The FDA issued a decision of Substantially Equivalent on September 26, 2025. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Wellspect AB has at least 2 other 510(k) clearances on record.