510(k) K133348 ยท ETN Stimulator, Nerve
STIM PROBE
| Applicant | Spes Medica Srl, Battipaglia, IT |
| Decision | Substantially Equivalent, Nov 21, 2014 |
| Received | Oct 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133348
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2021 | Spes Medica Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring. Terminated |
ETN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.