510(k) K200759 ยท GWF Stimulator, Electrical, Evoked Response
NIM Vital, Nerve Integrity Monitor
| Applicant | Medtronic Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Oct 28, 2020 |
| Received | Mar 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2025 | Medtronic Xomed, Inc. NIM Vital Nerve Monitoring System:
CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;
CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;
PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1;
PATIENT IN Open, Classified |
GWF | None listed |
| Jul 24, 2024 | Medtronic Xomed, Inc. NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3.
NIM Vital Nerve Integrity Monitor with below product descriptions. Open, Classified |
GWF | None listed |
| Jun 2, 2022 | Medtronic Xomed, Inc. NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 Open, Classified |
GWF | None listed |
| Jun 2, 2022 | Medtronic Xomed, Inc. NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 Open, Classified |
GWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.