# K110422: Surgical Stimulators

- Pathway: 510(k) (Traditional)
- Applicant: Technomed Europe
- Decided: May 26, 2011 after 101 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: 4 generations back to K980148 (1998). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031003: Stimulus/Dissection Instruments, Ball-Tip Probes, Medtronic Xomed, Inc. (2003) Summary page 1.

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

## Recalls of this device
- Jul 25, 2024 · Class II · Z-3131-2024: Product has have presence of brown discoloration or substance on the hinge area of the device

## Indications for use
The Kartush disposable surgical stimulators 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/K110422
Methodology: https://510kreport.com/methodology