510(k) K050084

COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; by Cosman Medical, Inc. — Product Code GXI

K050084 is an FDA 510(k) premarket notification submitted by Cosman Medical, Inc. for the device "COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;". The FDA issued a decision of Substantially Equivalent on March 17, 2005. 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.