# K040639: Isurg Disposable Subdermal Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Isurgical
- Decided: May 21, 2004 after 72 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: 4 generations back to K870795 (1987). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990015: Electrode Needles, Technomed Europe (1999) Summary page 1.
- K010019: Sterile Subdermal Needle Electrodes, Nicolet Biomedical, Inc. (2001) Summary page 1.
- K022914: Rhythmlink International Subdermal Needle Electrodes, Rhythmlink International, LLC (2002) Summary page 1.

## Indications for use
ISurg Disposable Subdermal Needle Electrodes are intended for use with monitoring, recording and electrical stimulation equipment specifically designed for the recording of biopotential signals from electroencephagraphy (EEG), electromyography (EMG) and nerve potential studies. ISurg Disposable Subdermal Needle Electrodes are "Rx Only", intended for "Single Use Only" and "Sterile".

Source page: https://510kreport.com/device/K040639
Methodology: https://510kreport.com/methodology