BIPOLAR ELECTROSURGICAL PENCIL

BIPOLAR ELECTROSURGICAL PENCIL is an FDA 510(k)-cleared medical device (K943031) manufactured by Boston Surgical Products, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 22, 1994. Regulation: 8.