INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM

INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM is an FDA 510(k)-cleared medical device (K090070) manufactured by Invuity, 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 April 21, 2009. Regulation: 8.