NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000

NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 is an FDA 510(k)-cleared medical device (K050650) manufactured by Cytyc Surgical Products. 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 May 15, 2005. Regulation: 8.