SpeediCath Flex Coude Pro

SpeediCath Flex Coude Pro is an FDA 510(k)-cleared medical device (K180070) 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 February 1, 2018. Regulation: 8.