ESOFLIP BALLOON DILATION CATHETER

ESOFLIP BALLOON DILATION CATHETER is an FDA 510(k)-cleared medical device (K132337) manufactured by Crospon, 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 October 6, 2013. Regulation: 8.