Advanix Biliary Stent with NaviFlex RX Delivery System

Advanix Biliary Stent with NaviFlex RX Delivery System is an FDA 510(k)-cleared medical device (K203162) manufactured by Boston Scientific Corporation. 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 December 17, 2020. Regulation: 8.