# K111597: Disposable Stimulating Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Oct 13, 2011 after 127 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
Longest line of descent: 6 generations back to K923056 (1992). 14 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,, Cadwell Lab, Inc. (2011) Summary page 1.
- K090838: Stimulus/Dissection Instruments, Axon Systems, Inc. (2009) Summary page 1.
- K031003: Stimulus/Dissection Instruments, Ball-Tip Probes, Medtronic Xomed, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own
- K191723: ATEC IOM Accessory Instruments (2019), 2 descendants of its own

## Indications for use
The NuVasive® Disposable Stimulating Electrode is indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

Source page: https://510kreport.com/device/K111597
Methodology: https://510kreport.com/methodology