DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)

DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) is an FDA 510(k)-cleared medical device (K090851) manufactured by Byrne Medical, 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 1, 2009. Regulation: 8.