
CenterPoint Systems, LLC
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RenaNav Ureteroscope System is an FDA 510(k)-cleared medical device (K223097) manufactured by CenterPoint Systems, LLC. 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 30, 2023. Regulation: 8.