Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle
FDA 510(k) K092973 · Bionen S.A.S.
510(k) numberK092973
Submission
- Device name
- Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle
- Applicant
- Bionen S.A.S.
Carmel, IN, US - Received
- September 25, 2009
- Decision date
- October 7, 2010
- 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 |
| K093825 | Ambu Neuroline Disposable Inoject Needle ElectrodeIKT · Special | Ambu A/S | 01/13/2010SE |
| K091410 | Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,IKT · Traditional | Spes Medica Srl | 08/11/2009SE |
Questions and answers
When was Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle cleared by the FDA?
Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle (K092973) received a 510(k) decision of Substantially Equivalent on October 7, 2010, 377 days after the submission was received.
What is the product code of K092973?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.