MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)

MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) is an FDA 510(k)-cleared medical device (K972119) manufactured by Medovations, 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 1, 1998. Regulation: 8.