INTRAUTERINE INSEMINATION (IUI) CATHETER

INTRAUTERINE INSEMINATION (IUI) CATHETER is an FDA 510(k)-cleared medical device (K120154) manufactured by Catheter Research, 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 March 20, 2012. Regulation: 8.