Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

FDA 510(k) K143433 · Natus Manufacturing Limited

Substantially Equivalent

510(k) numberK143433

Submission

Device name
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
Applicant
Natus Manufacturing Limited
Gort, IE
Received
December 1, 2014
Decision date
August 28, 2015
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

510(k)DeviceApplicantDecision
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
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
K173815Allergan Botox Needle ElectrodeIKT · Traditional 06/29/2018SE
K161430Myoject Luer Lock Needle ElectrodeIKT · Traditional 03/02/2017SE

Questions and answers

When was Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm cleared by the FDA?

Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm (K143433) received a 510(k) decision of Substantially Equivalent on August 28, 2015, 270 days after the submission was received.

What is the product code of K143433?

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