SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE

SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE is an FDA 510(k)-cleared medical device (K023902) manufactured by Usgi Medical, 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 August 19, 2003. Regulation: 8.