ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM is an FDA 510(k)-cleared medical device (K091816) 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 June 30, 2009. Regulation: 8.