510(k) K263512

Luja female by Coloplast Corp. — Product Code EZD

K263512 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Luja female". The FDA issued a decision of Substantially Equivalent on Oct 28, 2026. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Coloplast Corp. has 141 other 510(k) clearances on record.