510(k) K080791

CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 by Senorx, Inc. — Product Code JAQ

K080791 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45". The FDA issued a decision of SESU on April 30, 2008. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Senorx, Inc. has at least 10 other 510(k) clearances on record.