ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760

ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 is an FDA 510(k)-cleared medical device (K031262) 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 May 22, 2003. Regulation: 8.