
Medical Engineering Corp.
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SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET is an FDA 510(k)-cleared medical device (K902773) manufactured by Medical Engineering 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 July 15, 1990. Regulation: 8.