ESOPHAGEAL TTS STENT

ESOPHAGEAL TTS STENT is an FDA 510(k)-cleared medical device (K113551) manufactured by Taewoong Medical Co., Ltd.. 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 February 13, 2012. Regulation: 8.