
Uroviu Corporation
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Uro-G HD Cystoscope (1520) is an FDA 510(k)-cleared medical device (K243196) 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 December 12, 2024. Regulation: 8.