HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON

HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON is an FDA 510(k)-cleared medical device (K090183) manufactured by Cook Endoscopy. 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 September 24, 2009. Regulation: 8.