# K203684: Neurosign V4 Intraoperative Nerve Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Magstim Company, Ltd.
- Decided: Mar 17, 2021 after 90 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K980148 (1998). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181559: Neurosign V4 Intraoperative Nerve Monitor, Magstim Company, Ltd. (2018) Summary page 5.
- K053141: Neurosign Motor Nerve Monitor, Models Neurosign 400 & 800, The Magstim Company, Ltd. (2005) Summary page 5.

## 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/K203684
Methodology: https://510kreport.com/methodology