HEMEDEX FIXATION DEVICE

HEMEDEX FIXATION DEVICE is an FDA 510(k)-cleared medical device (K032127) manufactured by Hemedex Incorporated. 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 29, 2003. Regulation: 8.