CAD 12, COLONOSCOPY ASSIST DEVICE

CAD 12, COLONOSCOPY ASSIST DEVICE is an FDA 510(k)-cleared medical device (K092156) manufactured by Softscope Medical Technologies, Inc.. 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 13, 2009. Regulation: 8.