Uro-N Cystoscope

Uro-N Cystoscope is an FDA 510(k)-cleared medical device (K182876) manufactured by Uroviu Corporation. 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 1, 2019. Regulation: 8.