510(k) K160217

uVue HSG/SHG Catheter by Cook Incorporated — Product Code LKF

K160217 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "uVue HSG/SHG Catheter". The FDA issued a decision of Substantially Equivalent on October 6, 2016. 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.