WALLFLEX BILIARY RX STENT SYSTEM

WALLFLEX BILIARY RX STENT SYSTEM is an FDA 510(k)-cleared medical device (K140630) manufactured by Boston Scientific. 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 May 22, 2014. Regulation: 8.