MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM

MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM is an FDA 510(k)-cleared medical device (K072684) manufactured by Mondeal North America, 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 January 3, 2008. Regulation: 8.