# K112426: Xian Friendship Disposable Nerve Stimulator Probes

- Pathway: 510(k) (Traditional)
- Applicant: Xian Friendship Medical Electronics Co., Ltd.
- Decided: Apr 2, 2012 after 223 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). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062996: Disposable Monopolar and Bipolar Stimulator Probes, Axon Systems, Inc. (2007) Summary page 1.
- K031003: Stimulus/Dissection Instruments, Ball-Tip Probes, Medtronic Xomed, Inc. (2003) Summary page 1.
- K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,, Cadwell Lab, Inc. (2011) Summary page 1.

## Most influential descendants
- K133348: Stim Probe (2014), 1 descendant of its own
- K152769: Fremap Electrode (2016), 0 descendants of its own

## Indications for use
Xian Friendship Disposable Nerve Stimulator Probes is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. Xian Friendship Disposable Nerve Stimulator Probes are sterile (EtO), single-patient-use device.

Source page: https://510kreport.com/device/K112426
Methodology: https://510kreport.com/methodology