Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter is an FDA 510(k)-cleared medical device (K180086) manufactured by Gyrus Acmi, 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 March 7, 2018. Regulation: 8.