ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR

ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR is an FDA 510(k)-cleared medical device (K071553) manufactured by Ndo Surgical, Inc.. 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 September 17, 2007. Regulation: 8.