IUI CATHETER, MODEL 9057

IUI CATHETER, MODEL 9057 is an FDA 510(k)-cleared medical device (K052059) manufactured by Inntec, 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 November 21, 2005. Regulation: 8.