EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE

EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE is an FDA 510(k)-cleared medical device (K042741) 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 October 18, 2004. Regulation: 8.