FCP-9P, FIBER CHOLEDOCHOSCOPE

FCP-9P, FIBER CHOLEDOCHOSCOPE is an FDA 510(k)-cleared medical device (K953286) 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 November 2, 1995. Regulation: 8.