Re-Usable Concentric Needle
FDA 510(k) K953887 · Chalgren Enterprises, Inc.
510(k) numberK953887
Submission
- Device name
- Re-Usable Concentric Needle
- Applicant
- Chalgren Enterprises, Inc.
Gilroy, CA, US - Received
- August 17, 1995
- Decision date
- October 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K982950 | Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550IKT · Traditional | 06/22/1999SE |
| K960591 | Re-Usable Bipolar Concentric NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPIKT · Traditional | 06/13/1996SE |
| K955335 | Disposable Hypodermic Monopolar Needle Recording ElectrodeIKT · Traditional | 01/29/1996SE |
| K953361 | Emg Disc Recording ElectrodeGXY · Traditional | 01/22/1996SE |
| K953356 | Emg Recording Ring ElectrodeGXY · Traditional | 01/22/1996SE |
| K953354 | Emg Disc Recording ElectrodeGXY · Traditional | 01/22/1996SE |
| K952908 | Emg Disc Recording Electrode with PinGXY · Traditional | 12/06/1995SE |
| K952690 | Emg Disc Recording Electrode with PinGXY · Traditional | 12/06/1995SE |
| K953886 | Re-Usable Monopolar NeedleIKT · Traditional | 10/31/1995SE |
| K953220 | 32MM Nickel Plated Disc ElectrodeGXY · Traditional | 10/06/1995SE |
Questions and answers
When was Re-Usable Concentric Needle cleared by the FDA?
Re-Usable Concentric Needle (K953887) received a 510(k) decision of Substantially Equivalent on October 31, 1995, 75 days after the submission was received.
What is the product code of K953887?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.