GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM

GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM is an FDA 510(k)-cleared medical device (K012628) manufactured by Gynecare Center. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 25, 2001. Regulation: 8.