FC-38LX, FIBER COLONOSCOPE

FC-38LX, FIBER COLONOSCOPE is an FDA 510(k)-cleared medical device (K951578) 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 June 26, 1995. Regulation: 8.