PrimeSight UltraView System

PrimeSight UltraView System is an FDA 510(k)-cleared medical device (K253905) manufactured by Cogentix Medical, 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 April 6, 2026. Regulation: 8.