Ultramatrix EUS Balloon

Ultramatrix EUS Balloon is an FDA 510(k)-cleared medical device (K180731) manufactured by United States Endoscopy Group, Inc. (Us 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 April 18, 2018. Regulation: 8.