WELLFLEX BILIARY RX STENT SYSTEM

WELLFLEX BILIARY RX STENT SYSTEM is an FDA 510(k)-cleared medical device (K061231) manufactured by Boston Scientific Corp. 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 August 31, 2006. Regulation: 8.