ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS

ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS is an FDA 510(k)-cleared medical device (K050910) 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 June 15, 2005. Regulation: 8.