MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS

MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS is an FDA 510(k)-cleared medical device (K053322) manufactured by Roei Medical Technologies, Ltd.. 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 January 5, 2006. Regulation: 8.