# K062996: Disposable Monopolar and Bipolar Stimulator Probes

- Pathway: 510(k) (Traditional)
- Applicant: Axon Systems, Inc.
- Decided: Jan 12, 2007 after 102 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: 3 generations back to K923056 (1992). 6 ancestors in all.
32 later devices descend from it; 7 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe, Technomed Europe (2005) Summary page 1.
- K992869: Xomed Ball-Tip Monopolar Stimulator Probe, Xomed, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K112709: Stimulation/Dissection Instruments (2012), 9 descendants of its own

## Indications for use
To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Source page: https://510kreport.com/device/K062996
Methodology: https://510kreport.com/methodology