ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE

ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE is an FDA 510(k)-cleared medical device (K040639) manufactured by Isurgical. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 20, 2004. Regulation: 8.