510(k) K041062

INTRAUTERINE VENOGRAM NEEDLE SET by Cook Urological, Inc. — Product Code LKF

K041062 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "INTRAUTERINE VENOGRAM NEEDLE SET". The FDA issued a decision of Substantially Equivalent on October 1, 2004. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.