Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter

Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter is an FDA 510(k)-cleared medical device (K143609) 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 March 26, 2015. Regulation: 8.