
Gynecare Innovation Center
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FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) is an FDA 510(k)-cleared medical device (K964892) manufactured by Gynecare Innovation Center. 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 February 3, 1997. Regulation: 8.