ZUTRON COLONOSCOPE STIFFENING DEVICE

ZUTRON COLONOSCOPE STIFFENING DEVICE is an FDA 510(k)-cleared medical device (K051068) manufactured by Zutron Medical. 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 10, 2005. Regulation: 8.