510(k) K221593

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus by Convatec, Inc. — Product Code EZD

K221593 is an FDA 510(k) premarket notification submitted by Convatec, Inc. for the device "Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus". The FDA issued a decision of Substantially Equivalent on November 17, 2022. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Convatec, Inc. has at least 10 other 510(k) clearances on record.