510(k) K021311

SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL by Cp Medical — Product Code KXK

K021311 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL". The FDA issued a decision of Substantially Equivalent on July 13, 2002. 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.