FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5

FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 is an FDA 510(k)-cleared medical device (K041903) manufactured by Fujinon, Inc.. 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 9, 2004. Regulation: 8.