# K181559: Neurosign V4 Intraoperative Nerve Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Magstim Company, Ltd.
- Decided: Nov 9, 2018 after 149 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K980148 (1998). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083124: NIM 3.0, Medtronic Xomed, Inc. (2009) Summary page 4.
- K053141: Neurosign Motor Nerve Monitor, Models Neurosign 400 & 800, The Magstim Company, Ltd. (2005) Summary page 4.

## Most influential descendants
- K203684: Neurosign V4 Intraoperative Nerve Monitor (2021), 0 descendants of its own

## Recalls of this device
- Jun 23, 2020 · Class II · Z-2884-2020: Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the internal con

## Indications for use
The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots. Indications for Neurosign® V4 EMG Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities. Indications for spinal procedures which may use Neurosign® V4 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery and Open and Percutaneous Lumbar Procedures.

Source page: https://510kreport.com/device/K181559
Methodology: https://510kreport.com/methodology