FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU

FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU is an FDA 510(k)-cleared medical device (K964441) 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 27, 1997. Regulation: 8.