OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13

OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 is an FDA 510(k)-cleared medical device (K060243) manufactured by Olympus Medical Systems Corporation. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 2006. Regulation: 8.