FEMRX OPERASTAR SYSTEM

FEMRX OPERASTAR SYSTEM is an FDA 510(k)-cleared medical device (K954648) manufactured by Gynecare Innovation Center. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 13, 1996. Regulation: 8.