510(k) K080565

MODIFICATION TO: SAVI APPLICATOR KIT by Cianna Medical, Inc. — Product Code JAQ

K080565 is an FDA 510(k) premarket notification submitted by Cianna Medical, Inc. for the device "MODIFICATION TO: SAVI APPLICATOR KIT". The FDA issued a decision of SESU on April 4, 2008. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Cianna Medical, Inc. has at least 9 other 510(k) clearances on record.