INTRAUTERINE INSEMINATION (IUI) CATHETER

INTRAUTERINE INSEMINATION (IUI) CATHETER is an FDA 510(k)-cleared medical device (K092579) manufactured by Fertiligent, Ltd.. 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 April 1, 2010. Regulation: 8.