FLEXI-FLATE PENILE IMPLANT

FLEXI-FLATE PENILE IMPLANT is an FDA 510(k)-cleared medical device (K834347) 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 April 1, 1984. Regulation: 8.