# K173815: Allergan Botox Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Natus Manufacturing Limited
- Decided: Jun 29, 2018 after 196 days
- Product code: IKT (Electrode, Needle, Diagnostic Electromyograph)
- Device class: 2
- Regulation: 21 CFR 890.1385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973444 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973444: Teca Myoject Disposable Needle Electrodes, Medelec, Inc. D.B.A. Teca Corp. (1997) Summary page 4.

## Indications for use
The Allergan Botox Needle Electrode are for SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.

Source page: https://510kreport.com/device/K173815
Methodology: https://510kreport.com/methodology