IKT — Electrode, Needle, Diagnostic Electromyograph Class II
FDA product code IKT covers "Electrode, Needle, Diagnostic Electromyograph", a Class II medical device regulated under 21 CFR 890.1385. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IKT
- Device Class
- Class II
- Regulation Number
- 890.1385
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253581 | technomed europe | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable | March 15, 2026 |
| K173815 | natus manufacturing limited | Allergan Botox Needle Electrode | June 29, 2018 |
| K161430 | natus manufacturing limited | Myoject Luer Lock Needle Electrode | March 2, 2017 |
| K152984 | bio protech | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, | June 3, 2016 |
| K143433 | natus manufacturing limited | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable C | August 28, 2015 |
| K120342 | rhythmlink international | EMG RECORDING ELECTRODE ASSEMBLY | June 22, 2012 |
| K112034 | carefusion 209 | TECA ELITE DISPOSABLE CONCENTRIC NEEDLES | August 12, 2011 |
| K111131 | carefusion 209 | TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES | June 17, 2011 |
| K092973 | bionen | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR N | October 7, 2010 |
| K093825 | ambu | AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE | January 13, 2010 |
| K091410 | spes medica | DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, | August 11, 2009 |
| K091056 | rhythmlink international | RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R | June 23, 2009 |
| K091055 | rhythmlink international | RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R | June 23, 2009 |
| K080914 | rochester electro medical | ULTRASHARP CONCENTRIC NEEDLES | July 15, 2008 |
| K071186 | ambu | MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE | July 30, 2007 |
| K062437 | technomed europe | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE | February 16, 2007 |
| K020907 | medicotest | NEUROLINE, SUBDERMAL NEEDLE ELECTRODES | June 14, 2002 |
| K011818 | nicolet biomedical | STERILE EMG ELECTRODES | September 6, 2001 |
| K002992 | medtronic functional diagnostics | DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013 | August 15, 2001 |
| K001869 | medicotest | DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE | September 18, 2000 |