FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE

FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE is an FDA 510(k)-cleared medical device (K810503) manufactured by Olympus 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 April 2, 1981. Regulation: 8.