MODIFICATION TO:ENDIUS BIPOLAR SHEATH

MODIFICATION TO:ENDIUS BIPOLAR SHEATH is an FDA 510(k)-cleared medical device (K012488) manufactured by Endius, Inc.. 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 August 29, 2001. Regulation: 8.