GYRUS ACMI BICOAG HEMOSTASIS PROBE

GYRUS ACMI BICOAG HEMOSTASIS PROBE is an FDA 510(k)-cleared medical device (K123319) manufactured by Olympus Surgical Technologies America. 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 December 13, 2012. Regulation: 8.