510(k) K062937

TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU by Baylis Medical Co., Inc. — Product Code GXI

K062937 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU". The FDA issued a decision of Substantially Equivalent on January 8, 2007. 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.