510(k) K180291

Cook Silicone Balloon HSG Catheter by Cook Incorporated — Product Code LKF

K180291 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Cook Silicone Balloon HSG Catheter". The FDA issued a decision of Substantially Equivalent on October 26, 2018. 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.