
Medical Engineering Corp.
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SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 is an FDA 510(k)-cleared medical device (K880801) 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 May 25, 1988. Regulation: 8.