R STENT BILIARY ENDOPROSTHESIS

R STENT BILIARY ENDOPROSTHESIS is an FDA 510(k)-cleared medical device (K010107) manufactured by Orbus Medical Technologies. 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 30, 2001. Regulation: 8.