OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2

OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 is an FDA 510(k)-cleared medical device (K100899) manufactured by Keymed (Medical & Industrial Equipment), Ltd.. 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 September 12, 2010. Regulation: 8.