VTU-1 VACUUM ERECTION SYSTEM

VTU-1 VACUUM ERECTION SYSTEM is an FDA 510(k)-cleared medical device (K971257) manufactured by Mckenna & Cuneo. 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 October 2, 1997. Regulation: 8.