510(k) K062937 ยท GXI Probe, Radiofrequency Lesion
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
| Applicant | Baylis Medical Co., Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Jan 8, 2007 |
| Received | Sep 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062937
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2010 | Baylis Medical Corp * The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-1 Terminated |
GXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.