BULLSEYE BILIARY STENT SYSTEM

BULLSEYE BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K082093) manufactured by Squareone. 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 28, 2009. Regulation: 8.