SPEEDICATH COMPACT SET (12 FR)

SPEEDICATH COMPACT SET (12 FR) is an FDA 510(k)-cleared medical device (K121457) manufactured by Coloplast Corp.. 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 October 1, 2012. Regulation: 8.