ED-3410, VIDEO DUODENOSCOPE

ED-3410, VIDEO DUODENOSCOPE is an FDA 510(k)-cleared medical device (K963056) manufactured by Pentax Precision Instrument Corp.. 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 October 9, 1996. Regulation: 8.