SCOPE INTRODUCER MODEL 7400

SCOPE INTRODUCER MODEL 7400 is an FDA 510(k)-cleared medical device (K093329) manufactured by N.M. Beale Co., 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 February 15, 2010. Regulation: 8.