DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150

DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 is an FDA 510(k)-cleared medical device (K880951) manufactured by Advanced Surgical Products, 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 April 12, 1988. Regulation: 8.