SHAPE LOCKING ENDOSCOPIC OVERTUBE

SHAPE LOCKING ENDOSCOPIC OVERTUBE is an FDA 510(k)-cleared medical device (K033954) 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 March 18, 2004. Regulation: 8.