# K973444: Teca Myoject Disposable Needle Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Medelec, Inc. D.B.A. Teca Corp.
- Decided: Nov 20, 1997 after 70 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
No predicates in its family tree.
11 later devices descend from it; 6 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K062437: Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled (2007), 6 descendants of its own
- K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, (2013), 3 descendants of its own
- 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
- K241045: Disposable Subdermal Needle Electrode, Corkscrew (2024), 0 descendants of its own

## Indications for use
The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to hléetfanelechode, infl\efomofapmbe, mbapaflentblomlea patticular muscle and then inject a medication into that muscle. The hypodetmicmedlewifllanopm!umenisdesignedformusde 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. Note: TECA Corp. does not supply any drugs with needle electrodes nor does TECA Corp. offer for sale any form of drugs.

Source page: https://510kreport.com/device/K973444
Methodology: https://510kreport.com/methodology