NIROYAL BILIARY PREMOUNTED STENT SYSTEM

NIROYAL BILIARY PREMOUNTED STENT SYSTEM is an FDA 510(k)-cleared medical device (K012216) manufactured by Boston Scientific Scimed, 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 August 16, 2001. Regulation: 8.