510(k) K241028

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) by Coloplast — Product Code EZD

K241028 is an FDA 510(k) premarket notification submitted by Coloplast for the device "Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)". The FDA issued a decision of Substantially Equivalent on July 26, 2024. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Coloplast has at least 10 other 510(k) clearances on record.