# K021118: Detachable Monopolar Emg Needle, Models 610-725, 610-737, 610-637, 610-744, 610-650, 610-570

- Pathway: 510(k) (Special)
- Applicant: Class A Ent.
- Decided: May 28, 2002 after 50 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
Electromyographic (EMG) needle electrodes are monopolar needles intended to be inserted into the muscle or nerve tissue to sense bioelectrical signals. This device is an accessory to the electromygraphy machine, which is for use in connection with electromyography studies (recording the intrinsic electrical properties of skeletal muscles). EMG electrodes are indicated for use by or on the order of a licensed physician and intended for single patient use, only.

Source page: https://510kreport.com/device/K021118
Methodology: https://510kreport.com/methodology