DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]

DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] is an FDA 510(k)-cleared medical device (K954174) manufactured by Origin Medsystems, 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 November 8, 1995. Regulation: 8.