COLOPLAST OSTOMY ROD, MODEL 12814

COLOPLAST OSTOMY ROD, MODEL 12814 is an FDA 510(k)-cleared medical device (K052229) 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 12, 2006. Regulation: 8.