FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM

FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM is an FDA 510(k)-cleared medical device (K971305) 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 August 10, 1997. Regulation: 8.