SpeediCath Flex Coude Pro

SpeediCath Flex Coude Pro is an FDA 510(k)-cleared medical device (K190620) 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 July 9, 2019. Regulation: 8.