HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)

HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP) is an FDA 510(k)-cleared medical device (K863136) manufactured by Neurotechnics, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1987. Regulation: 8.