MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22

MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 is an FDA 510(k)-cleared medical device (K080550) manufactured by Minos 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 June 9, 2008. Regulation: 8.