FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM is an FDA 510(k)-cleared medical device (K121125) manufactured by Flexible Stenting Solutions, 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 5, 2012. Regulation: 8.