Teca Myoject Disposable Needle Electrodes

FDA 510(k) K973444 · Medelec, Inc. D.B.A. Teca Corp.

Substantially Equivalent

510(k) numberK973444

Submission

Device name
Teca Myoject Disposable Needle Electrodes
Applicant
Medelec, Inc. D.B.A. Teca Corp.
Pleasantville, NY, US
Received
September 11, 1997
Decision date
November 20, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IKT – Electrode, Needle, Diagnostic Electromyograph
Device class
Class II (moderate risk)
Regulation
21 CFR 890.1385
Specialty
Physical Medicine

Other 510(k)s with product code IKT

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K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional Technomed Europe03/15/2026SE
K173815Allergan Botox Needle ElectrodeIKT · Traditional Natus Manufacturing Limited06/29/2018SE
K161430Myoject Luer Lock Needle ElectrodeIKT · Traditional Natus Manufacturing Limited03/02/2017SE
K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…IKT · Traditional Bio Protech, Inc.06/03/2016SE
K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…IKT · Traditional Natus Manufacturing Limited08/28/2015SE
K120342Emg Recording Electrode AssemblyIKT · Traditional Rhythmlink International, LLC06/22/2012SE
K112034Teca Elite Disposable Concentric NeedlesIKT · Special Carefusion 209, Inc.08/12/2011SE
K111131Teca (TM) Elite Disposable Monopolar NeedlesIKT · Special Carefusion 209, Inc.06/17/2011SE
K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleIKT · Traditional Bionen S.A.S.10/07/2010SE
K093825Ambu Neuroline Disposable Inoject Needle ElectrodeIKT · Special Ambu A/S01/13/2010SE

More from Ambu A/S

510(k)DeviceDecision
K971914Teca NCS Electrode System 2000GXY · Traditional 03/26/1998SE
K973442Teca Disposable Monopolar Needle ElectrodesIKT · Traditional 11/20/1997SE

Questions and answers

When was Teca Myoject Disposable Needle Electrodes cleared by the FDA?

Teca Myoject Disposable Needle Electrodes (K973444) received a 510(k) decision of Substantially Equivalent on November 20, 1997, 70 days after the submission was received.

What is the product code of K973444?

The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.