510(k) K233101

Luja Coude (20108 Male CH18 - large packaging) by Coloplast Corp. — Product Code EZD

K233101 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Luja Coude (20108 Male CH18 - large packaging)". The FDA issued a decision of Substantially Equivalent on October 26, 2023. 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.