
Uro-1, Inc.
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Repris Bladder Injection System is an FDA 510(k)-cleared medical device (K180214) manufactured by Uro-1, 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 May 2, 2018. Regulation: 8.