MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE

MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE is an FDA 510(k)-cleared medical device (K050361) manufactured by Boston Scientific Corp. 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 March 13, 2005. Regulation: 8.