SINGLE USE BALLOON DILATOR MAXPASSTM

SINGLE USE BALLOON DILATOR MAXPASSTM is an FDA 510(k)-cleared medical device (K050502) manufactured by Olympus Winter & Ibe GmbH. 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 July 7, 2005. Regulation: 8.