MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE

MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE is an FDA 510(k)-cleared medical device (K051919) manufactured by Usgi Medical. 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 July 25, 2005. Regulation: 8.