BARE Wireguided Balloon Dilation Catheter (1235)

BARE Wireguided Balloon Dilation Catheter (1235) is an FDA 510(k)-cleared medical device (K253987) manufactured by GIE Medical. 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 12, 2026. Regulation: 8.