# K031003: Stimulus/Dissection Instruments, Ball-Tip Probes

- Pathway: 510(k) (Special)
- Applicant: Medtronic Xomed, Inc.
- Decided: Apr 11, 2003 after 11 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980148 (1998). 3 ancestors in all.
35 later devices descend from it; 9 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)
- K014165: Stimulus - Dissection Instruments, Medtronic Xomed, Inc. (2002)
- K992869: Xomed Ball-Tip Monopolar Stimulator Probe, Xomed, Inc. (1999) Summary page 2.

## Most influential descendants
- K090838: Stimulus/Dissection Instruments (2009), 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
- K110419: Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators (2011), 9 descendants of its own

## Recalls of this device
- Nov 21, 2008 · Not classified · Z-0947-2009: Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.

## Indications for use
The Stimulus - Dissection Instruments are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Source page: https://510kreport.com/device/K031003
Methodology: https://510kreport.com/methodology