OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE

OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE is an FDA 510(k)-cleared medical device (K982734) manufactured by The Olympus Optical Co.. 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 October 4, 1998. Regulation: 8.