510(k) K210250

SpeedCath Compact Male by Coloplast — Product Code EZD

K210250 is an FDA 510(k) premarket notification submitted by Coloplast for the device "SpeedCath Compact Male". The FDA issued a decision of Substantially Equivalent on April 26, 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.