# K983597: Neuroline, Disposable Monopolar Needle Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Medicotest, Inc.
- Decided: Jan 11, 1999 after 90 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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.

## Most influential descendants
- K091410: Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, (2009), 2 descendants of its own
- K092973: Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle (2010), 1 descendant of its own
- K152984: Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes (2016), 0 descendants of its own

## Indications for use
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

Source page: https://510kreport.com/device/K983597
Methodology: https://510kreport.com/methodology