# K052111: Xltek Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382

- Pathway: 510(k) (Abbreviated)
- Applicant: Excel Tech., Ltd.
- Decided: Aug 17, 2005 after 13 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. The FDA summary names no predicate by number.

## Indications for use
XLTEK Clear Signal Sub-dermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and are for single patient use only.

Source page: https://510kreport.com/device/K052111
Methodology: https://510kreport.com/methodology