510(k) K082012

COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN by Cosman Medical, Inc. — Product Code GXI

K082012 is an FDA 510(k) premarket notification submitted by Cosman Medical, Inc. for the device "COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN". The FDA issued a decision of Substantially Equivalent on October 14, 2008. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Cosman Medical, Inc. has at least 5 other 510(k) clearances on record.