SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE

SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE is an FDA 510(k)-cleared medical device (K905015) manufactured by Surgitek. 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 27, 1990. Regulation: 8.