510(k) K034012 ยท GXI Probe, Radiofrequency Lesion
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Mar 16, 2004 |
| Received | Dec 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K034012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2007 | Smith & Nephew, Inc. Endoscopy Division RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain.
Part Number: 7210270 Terminated |
GXI | None listed |
| Mar 29, 2007 | Smith & Nephew, Inc. Endoscopy Division RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain.
Product Number: 7210271 Terminated |
GXI | None listed |
| Mar 29, 2007 | Smith & Nephew, Inc. Endoscopy Division RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain.
Product Number: 7210272 Terminated |
GXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.