510(k) K092136

PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 by Isoray Medical, Inc. — Product Code KXK

K092136 is an FDA 510(k) premarket notification submitted by Isoray Medical, Inc. for the device "PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5". The FDA issued a decision of Substantially Equivalent on August 7, 2009. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Isoray Medical, Inc. has at least 4 other 510(k) clearances on record.