# K062880: Subdermal Wire Electrode, Model Swe

- Pathway: 510(k) (Traditional)
- Applicant: Ives Eeg Solutions, Inc.
- Decided: Dec 22, 2006 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The subdermal wire electrode (SWE) is intended for temporary recording of EEG in comatose patients (age range: 6 years and up) in hospital based Intensive Care Units (ICU). The SWE is a disposable, single use device. The SWE is intended for use in a similar manner to that of a subdermal needle electrode.

Source page: https://510kreport.com/device/K062880
Methodology: https://510kreport.com/methodology