Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
FDA 510(k) K152984 · Bio Protech, Inc.
510(k) numberK152984
Submission
- Device name
- Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
- Applicant
- Bio Protech, Inc.
Wonju-Si, KR - Received
- October 9, 2015
- Decision date
- June 3, 2016
- 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 |
| 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 |
| K091410 | Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,IKT · Traditional | Spes Medica Srl | 08/11/2009SE |
More from Spes Medica Srl
| 510(k) | Device | Decision |
|---|---|---|
| K192035 | EvaQMax Smoke Evacuation SystemFYD · Traditional | 08/29/2019SE |
| K153019 | Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesGXY · Traditional | 03/21/2016SE |
| K143103 | PROPENCIL Smoke PencilGEI · Traditional | 07/16/2015SE |
| K142099 | Cutaneous ElectrodesGXY · Traditional | 11/17/2014SE |
| K111270 | Reusable Stimulating ElectrodesGXY · Traditional | 09/13/2011SE |
| K100246 | MAX-IF1000LIH · Traditional | 11/24/2010SE |
| K091248 | Maxems, Models 1000 and 2000IPF · Traditional | 11/30/2009SE |
| K092732 | Propencil Esu PencilGEI · Traditional | 11/25/2009SE |
| K092761 | Proplate, Models 9641C, 9641F, P9641C, P9641F, 9642C, 9642F and P9642CGEI · Special | 11/24/2009SE |
| K083148 | Telectrode Wet Gel ECG ElectrodeDRX · Traditional | 11/07/2008SE |
Questions and answers
When was Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes cleared by the FDA?
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes (K152984) received a 510(k) decision of Substantially Equivalent on June 3, 2016, 238 days after the submission was received.
What is the product code of K152984?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.