# K100912: Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator Probe, Bipolar Side by Side

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: Aug 19, 2010 after 140 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923056 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe, Technomed Europe (2005) Summary page 2.

## Indications for use
The Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes are intended to be connected to a nerve monitoring unit, such as the Neurosign 100 Nerve Monitor, which requires a standard 1.5mm DIN 42802 touch proof connector, in order to provide an electrical path by which electrical impulses may pass from the monitoring unit to the patient, thus effecting nerve stimulation to assist its user in locating and identifying motor nerves.

Source page: https://510kreport.com/device/K100912
Methodology: https://510kreport.com/methodology