GIVEN ELECTROSURGICAL NEEDLE

GIVEN ELECTROSURGICAL NEEDLE is an FDA 510(k)-cleared medical device (K082584) manufactured by Tripps Court Enterprises, 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 October 27, 2009. Regulation: 8.