510(k) K221401

Self-Cath and Self-Cath Plus by Coloplast — Product Code EZD

K221401 is an FDA 510(k) premarket notification submitted by Coloplast for the device "Self-Cath and Self-Cath Plus". The FDA issued a decision of Substantially Equivalent on December 2, 2022. 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.