MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS

MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS is an FDA 510(k)-cleared medical device (K041032) 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 May 9, 2004. Regulation: 8.