510(k) K053082

BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 by Baylis Medical Co., Inc. — Product Code GXI

K053082 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6". The FDA issued a decision of Substantially Equivalent on November 30, 2005. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.