Allergan Botox Needle Electrode

FDA 510(k) K173815 · Natus Manufacturing Limited

Substantially Equivalent

510(k) numberK173815

Submission

Device name
Allergan Botox Needle Electrode
Applicant
Natus Manufacturing Limited
Gort, IE
Received
December 15, 2017
Decision date
June 29, 2018
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

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K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional Technomed Europe03/15/2026SE
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
K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,IKT · Traditional Spes Medica Srl08/11/2009SE

More from Spes Medica Srl

510(k)DeviceDecision
K242346Grass® MR Conditional/CT Cup ElectrodesGXY · Traditional 08/29/2024SE
K161430Myoject Luer Lock Needle ElectrodeIKT · Traditional 03/02/2017SE
K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…IKT · Traditional 08/28/2015SE

Questions and answers

When was Allergan Botox Needle Electrode cleared by the FDA?

Allergan Botox Needle Electrode (K173815) received a 510(k) decision of Substantially Equivalent on June 29, 2018, 196 days after the submission was received.

What is the product code of K173815?

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