# K232581: Medical Disposable Sterile Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Haishen Medical Device Associates Co., Ltd.
- Decided: Dec 4, 2023 after 101 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: 5 generations back to K870795 (1987). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072276: Subdermal Needle Electrodes, Xian Friendship Electronics Co., Ltd. (2008) Summary page 5.

## Indications for use
This product is intended for use with recording, monitoring equipment for the recording of bioelectrical signals, such as electromyograph (EMG). The electrodes are sterile and for single patient use only.

Source page: https://510kreport.com/device/K232581
Methodology: https://510kreport.com/methodology