ELECTROSURGICAL GENERATOR MODEL ESU100/250/550

ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 is an FDA 510(k)-cleared medical device (K914367) manufactured by Gyne-Tech Instrument Corp.. 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 April 27, 1992. Regulation: 8.