MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019

MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019 is an FDA 510(k)-cleared medical device (K061135) manufactured by Aesculap. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 10, 2006. Regulation: 8.