OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER

OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER is an FDA 510(k)-cleared medical device (K991377) manufactured by Omnisonics Medical Technologies. 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 11, 1999. Regulation: 8.