ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400

ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 is an FDA 510(k)-cleared medical device (K023630) manufactured by Guidant Corporation, Cardiac Surgery. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 19, 2003. Regulation: 8.