MODIFICATION TO ENDO-EASE

MODIFICATION TO ENDO-EASE is an FDA 510(k)-cleared medical device (K062805) manufactured by Spirus 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 October 12, 2006. Regulation: 8.