510(k) K181770

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter by Cook Incorporated — Product Code LKF

K181770 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Intrauterine Access Balloon Catheter, Selective Salpingography Catheter". The FDA issued a decision of Substantially Equivalent on March 29, 2019. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Cook Incorporated has at least 10 other 510(k) clearances on record.