Modification to: Ambu Neuroline Concentric Needle Electrode
FDA 510(k) K071186 · Ambu A/S
510(k) numberK071186
Submission
- Device name
- Modification to: Ambu Neuroline Concentric Needle Electrode
- Applicant
- Ambu A/S
Glen Burnie, MD, US - Received
- April 30, 2007
- Decision date
- July 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional | Technomed Europe | 03/15/2026SE |
| K173815 | Allergan Botox Needle ElectrodeIKT · Traditional | Natus Manufacturing Limited | 06/29/2018SE |
| K161430 | Myoject Luer Lock Needle ElectrodeIKT · Traditional | Natus Manufacturing Limited | 03/02/2017SE |
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…IKT · Traditional | Bio Protech, Inc. | 06/03/2016SE |
| K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…IKT · Traditional | Natus Manufacturing Limited | 08/28/2015SE |
| K120342 | Emg Recording Electrode AssemblyIKT · Traditional | Rhythmlink International, LLC | 06/22/2012SE |
| K112034 | Teca Elite Disposable Concentric NeedlesIKT · Special | Carefusion 209, Inc. | 08/12/2011SE |
| K111131 | Teca (TM) Elite Disposable Monopolar NeedlesIKT · Special | Carefusion 209, Inc. | 06/17/2011SE |
| K092973 | Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleIKT · Traditional | Bionen S.A.S. | 10/07/2010SE |
| K093825 | Ambu Neuroline Disposable Inoject Needle ElectrodeIKT · Special | Ambu A/S | 01/13/2010SE |
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| K240849 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse…FAJ · Traditional | 10/16/2024SE |
| K240848 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse…FAJ · Traditional | 10/10/2024SE |
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| K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2FDT · Traditional | 04/16/2024SE |
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Questions and answers
When was Modification to: Ambu Neuroline Concentric Needle Electrode cleared by the FDA?
Modification to: Ambu Neuroline Concentric Needle Electrode (K071186) received a 510(k) decision of Substantially Equivalent on July 30, 2007, 91 days after the submission was received.
What is the product code of K071186?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.