PENTAX VIDEO COLONOSCOPES (EC FAMILY)

PENTAX VIDEO COLONOSCOPES (EC FAMILY) is an FDA 510(k)-cleared medical device (K131855) manufactured by Pentax Medical Company. 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 8, 2014. Regulation: 8.