SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE

SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE is an FDA 510(k)-cleared medical device (K862861) manufactured by Directed Energy, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 1986. Regulation: 8.