510(k) K011387 ยท GXI Probe, Radiofrequency Lesion
NEUROTHERM, MODEL JK4
| Applicant | Eurolink, LLC, Lynnfield MA, US |
| Decision | Substantially Equivalent, Sep 6, 2001 |
| Received | May 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011387
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Neurotherm, Inc. NeuroTherm Simplicity III RF Electrode
Model Number: RFDE-SI
The lesioning of neural tissue. Terminated |
GXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.