# K111647: C2 Nervemonitor System with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Inomed Medizintechnik GmbH
- Decided: Oct 6, 2011 after 115 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K980148 (1998). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 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 1.
- K083242: Neurosign Avalanche Motor Nerve Monitor, The Magstim Company, Ltd. (2009) Summary page 1.
- K991583: Neurosign 400, 4 Channel Motor Nerve Monitor, The Magstim Company, Ltd. (1999) Summary page 1.
- K992869: Xomed Ball-Tip Monopolar Stimulator Probe, Xomed, Inc. (1999) Summary page 1.
- K980148: Neurosign 800, 8 Channel Motor Nerve Monitor, The Magstim Company, Ltd. (1998) Summary page 1.
- K964869: Neurosign 800, 8 Channel Motor Nerve Monitor, The Magstim Company, Ltd. (1997) Summary page 1.

## Most influential descendants
- K152505: C2 NerveMonitor System (2016), 1 descendant of its own
- K223254: C2 Xplore (2023), 0 descendants of its own

## Indications for use
The 02 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The 02 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device Indications for 02 NerveMonitor System Monitoring Procedures include: Intracranial, Extracranial, Intratemporai, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities. Indications for 02 NerveMonitor System monitoring of Spinal procedures include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures and Thoracic Surgical Procedures. The system is not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death.

Source page: https://510kreport.com/device/K111647
Methodology: https://510kreport.com/methodology