510(k) K101372

DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 by Baylis Medical Co., Inc. — Product Code GXI

K101372 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20". The FDA issued a decision of Substantially Equivalent on August 10, 2010. 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.