
Coloplast
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Self-Cath and Self-Cath Plus is an FDA 510(k)-cleared medical device (K221401) manufactured by Coloplast. 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 December 1, 2022. Regulation: 8.