HICURA HAND INSTRUMENTS

HICURA HAND INSTRUMENTS is an FDA 510(k)-cleared medical device (K140624) manufactured by Olympus Winter & Ibe GmbH. 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 December 9, 2014. Regulation: 8.