CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION

CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION is an FDA 510(k)-cleared medical device (K933906) 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 July 7, 1994. Regulation: 8.