GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER

GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER is an FDA 510(k)-cleared medical device (K132181) manufactured by Olympus Surgical Technologies America. 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 20, 2013. Regulation: 8.