510(k) K251116

Luja Coudé by Coloplast Corp. — Product Code EZD

K251116 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Luja Coudé". The FDA issued a decision of Substantially Equivalent on June 27, 2025. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Coloplast Corp. has at least 10 other 510(k) clearances on record.