SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR

SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR is an FDA 510(k)-cleared medical device (K070783) manufactured by Sopro. 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 December 12, 2007. Regulation: 8.