ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM

ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K072720) manufactured by Alveolus, 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 April 10, 2008. Regulation: 8.