AMSURE BLADDER IRRIGATION SET

AMSURE BLADDER IRRIGATION SET is an FDA 510(k)-cleared medical device (K070873) manufactured by Amsino Intl., 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 December 18, 2007. Regulation: 8.