COOK GASTRIC SIZING BALLOON CATHETER

COOK GASTRIC SIZING BALLOON CATHETER is an FDA 510(k)-cleared medical device (K030841) manufactured by Cook, 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 July 10, 2003. Regulation: 8.