
Pentax Precision Instrument Corp.
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PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P is an FDA 510(k)-cleared medical device (K914008) manufactured by Pentax Precision Instrument 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 9, 1992. Regulation: 8.