510(k) K053082 ยท GXI Probe, Radiofrequency Lesion
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
| Applicant | Baylis Medical Co., Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Nov 30, 2005 |
| Received | Nov 2, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2016 | Halyard Health, Inc Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue. Terminated |
GXI | None listed |
| 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.