ARCHSTENT BILIARY SYSTEM

ARCHSTENT BILIARY SYSTEM is an FDA 510(k)-cleared medical device (K113582) manufactured by Ostial Corporation. 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 June 28, 2012. Regulation: 8.