OLYMPUS MH-246R BALLOON SHEATH

OLYMPUS MH-246R BALLOON SHEATH is an FDA 510(k)-cleared medical device (K961048) manufactured by Olympus America, 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 September 15, 1996. Regulation: 8.