NITI-S BILIARY STENT

NITI-S BILIARY STENT is an FDA 510(k)-cleared medical device (K073667) manufactured by Taewoong Medical Co., Ltd.. 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 November 18, 2008. Regulation: 8.