Electrode Needles
FDA 510(k) K990015 · Technomed Europe
510(k) numberK990015
Submission
- Device name
- Electrode Needles
- Applicant
- Technomed Europe
6191 Bg Beek, NL - Received
- January 4, 1999
- Decision date
- May 27, 1999
- 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 |
More from Ambu A/S
| 510(k) | Device | Decision |
|---|---|---|
| K254183 | MR Conditional Cup ElectrodesGXY · Traditional | 05/07/2026SE |
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional | 03/15/2026SE |
| K241045 | Disposable Subdermal Needle Electrode, CorkscrewGXZ · Traditional | 12/11/2024SE |
| K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…GXZ · Traditional | 07/19/2013SE |
| K121257 | Laryngeal ElectrodeETN · Traditional | 08/28/2012SE |
| K110422 | Surgical StimulatorsETN · Traditional | 05/26/2011SE |
| K073532 | Disposable Adhesive Surface Electrodes, Disc ElectrodesGXY · Traditional | 05/01/2008SE |
| K072016 | Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride…GXY · Traditional | 10/19/2007SE |
| K063729 | Disposable Pedicle Screw Probe, Model 3603-00GXZ · Traditional | 08/21/2007SE |
| K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledIKT · Traditional | 02/16/2007SE |
Questions and answers
When was Electrode Needles cleared by the FDA?
Electrode Needles (K990015) received a 510(k) decision of Substantially Equivalent on May 27, 1999, 143 days after the submission was received.
What is the product code of K990015?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.