# K123589: Cadwell Disposable Probe Handle

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell
- Decided: Mar 19, 2013 after 118 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- 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
No predicates in its family tree.
6 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)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic/Xomed NIM Incrementing Probe Handle: named in the summary without a submission number
- (no number) NuVasive Neurovision Probe Handle: named in the summary without a submission number

## Most influential descendants
- K132373: Biomet Access System (2014), 5 descendants of its own
- K142438: Nerve Monitoring Cable System (2015), 4 descendants of its own
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own
- K191723: ATEC IOM Accessory Instruments (2019), 2 descendants of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own

## Indications for use
The Cadwell Disposable Probe Handle is a component of the Cadwell Kilowin System that 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. The Cadwell Disposable Probe Handle is a sterile, disposable, single patient use device.

Source page: https://510kreport.com/device/K123589
Methodology: https://510kreport.com/methodology