GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910

GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 is an FDA 510(k)-cleared medical device (K061417) manufactured by Genicon. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 9, 2006. Regulation: 8.