# K133348: Stim Probe

- Pathway: 510(k) (Traditional)
- Applicant: Spes Medica Srl
- Decided: Nov 21, 2014 after 387 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: 7 generations back to K923056 (1992). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112435: Rhythmlink Monopolar Stimulating Instrument, Rhythmlink International, LLC (2011) Summary page 4.
- K110712: Drytouch Suction Stimulator Probe, Neurovision Medical Products, Inc. (2011) Summary page 4.
- K112426: Xian Friendship Disposable Nerve Stimulator Probes, Xian Friendship Medical Electronics Co., Ltd. (2012) Summary page 4.
- K110422: Surgical Stimulators, Technomed Europe (2011) Summary page 4.
- K031003: Stimulus/Dissection Instruments, Ball-Tip Probes, Medtronic Xomed, Inc. (2003) Summary page 4.

## Most influential descendants
- K152769: Fremap Electrode (2016), 0 descendants of its own

## Recalls of this device
- Apr 8, 2021 · Class II · Z-1971-2021: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

## Indications for use
IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identitY nerves and spinal nerve roots and to assess nerve function. 10M Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.

Source page: https://510kreport.com/device/K133348
Methodology: https://510kreport.com/methodology