510(k) K053415

LESIONPOINT RF CANNULA by Cosman Medical, Inc. — Product Code GXI

K053415 is an FDA 510(k) premarket notification submitted by Cosman Medical, Inc. for the device "LESIONPOINT RF CANNULA". The FDA issued a decision of Substantially Equivalent on April 25, 2006. 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.