
Expanded Optics, Inc.
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OMNI CYSTOSCOPE is an FDA 510(k)-cleared medical device (K922320) manufactured by Expanded Optics, 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 January 12, 1993. Regulation: 8.