Agile Esophageal Stent System

Agile Esophageal Stent System is an FDA 510(k)-cleared medical device (K180144) manufactured by Boston Scientific Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 2018. Regulation: 8.