Uro-G HD Flexible Cystoscope

Uro-G HD Flexible Cystoscope is an FDA 510(k)-cleared medical device (K232837) 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 June 6, 2024. Regulation: 8.