ENDOSOPIC STENE MANIPULATING BALLOON

ENDOSOPIC STENE MANIPULATING BALLOON is an FDA 510(k)-cleared medical device (K850489) manufactured by Mill-Rose Laboratory. 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 April 21, 1985. Regulation: 8.