510(k) K092458

PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 by Isoray Medical, Inc. — Product Code KXK

K092458 is an FDA 510(k) premarket notification submitted by Isoray Medical, Inc. for the device "PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2". The FDA issued a decision of Substantially Equivalent on August 28, 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.