CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT

CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT is an FDA 510(k)-cleared medical device (K911053) manufactured by Circon Video. 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 June 2, 1991. Regulation: 8.