ENCIRCLE LOCALIZATION DEVICE

ENCIRCLE LOCALIZATION DEVICE is an FDA 510(k)-cleared medical device (K022286) manufactured by Vivant 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 10, 2002. Regulation: 8.