
Convatec, Inc.
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Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is an FDA 510(k)-cleared medical device (K221593) manufactured by Convatec, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 16, 2022. Regulation: 8.