# K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe

- Pathway: 510(k) (Traditional)
- Applicant: Technomed Europe
- Decided: May 5, 2005 after 85 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923056 (1992). 4 ancestors in all.
38 later devices descend from it; 4 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991583: Neurosign 400, 4 Channel Motor Nerve Monitor, The Magstim Company, Ltd. (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
- K062996: Disposable Monopolar and Bipolar Stimulator Probes (2007), 32 descendants of its own
- K090838: Stimulus/Dissection Instruments (2009), 19 descendants of its own
- K063729: Disposable Pedicle Screw Probe, Model 3603-00 (2007), 19 descendants of its own
- K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe, (2011), 17 descendants of its own
- K111597: Disposable Stimulating Electrode (2011), 10 descendants of its own

## Indications for use
The disposable probe is used: - to locate and identify cranial motor nerves during ENT and intra-cranial procedures - to locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots - to locate, identify and monitor cranial motor nerves during surgery The motor nerves are monitored by detecting EMG activity in the muscles they innervate

Source page: https://510kreport.com/device/K050325
Methodology: https://510kreport.com/methodology