NIM Vital, Nerve Integrity Monitor— 510(k) K200759
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K200759 for NIM Vital, Nerve Integrity Monitor, Substantially Equivalent on 2020-10-28. Applicant: Medtronic Xomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Xomed, Inc.
- Product code
- Code GWF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1870
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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Adverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K200759
K-number listed on FDA's recall record- Z-1623-2025 — 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 INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164
- Z-2409-2024 — 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. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143
- Z-1223-2022 — NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
- Z-1224-2022 — NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200759.
Data sourced from openFDA. This site is unofficial and independent of the FDA.