510(k) K071550

PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS by Cp Medical — Product Code KXK

K071550 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS". The FDA issued a decision of Substantially Equivalent on July 18, 2007. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Cp Medical has at least 10 other 510(k) clearances on record.