# K062549: Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and 105238

- Pathway: 510(k) (Traditional)
- Applicant: Excel Tech., Ltd.
- Decided: Oct 4, 2006 after 35 days
- Product code: ETN (Stimulator, Nerve)
- 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
No predicates in its family tree.
18 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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
- K132373: Biomet Access System (2014), 5 descendants of its own
- K142438: Nerve Monitoring Cable System (2015), 4 descendants of its own

## Indications for use
The XLTEK Stimulator Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. The probes are sterile and are for single patient use only.

Source page: https://510kreport.com/device/K062549
Methodology: https://510kreport.com/methodology