
Olympus Corp.
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FLEXIBLE AND RIGID URETEROTOME SYSTEM is an FDA 510(k)-cleared medical device (K904939) manufactured by Olympus Corp.. 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 January 6, 1992. Regulation: 8.