Intrauterine Access Balloon Catheter, Selective Salpingography Catheter

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter is an FDA 510(k)-cleared medical device (K181770) manufactured by Cook Incorporated. 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 28, 2019. Regulation: 8.