FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
ELECTRODE NEEDLES
K Number: K990015
·
Decision May 27, 1999
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
42
Applicant Total
13
Review Days
143
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Basic Information
- Device Name
- ELECTRODE NEEDLES
- K Number
- K990015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1385
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Technomed Europe
- Date Received
- January 4, 1999
- Decision Date
- May 27, 1999
- Product Code
- IKT
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IKT | Electrode, Needle, Diagnostic Electromyograph | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IKT), ordered by most recent decision date.
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)
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Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
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EMG RECORDING ELECTRODE ASSEMBLY
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Other Clearances by Technomed Europe
| K Number | Device Name | ||
|---|---|---|---|
| K254183 | MR Conditional Cup Electrodes | May 7, 2026 | Substantially Equivalent |
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | Mar 15, 2026 | Substantially Equivalent |
| K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Dec 11, 2024 | Substantially Equivalent |
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, | Jul 19, 2013 | Substantially Equivalent |
| K121257 | LARYNGEAL ELECTRODE | Aug 28, 2012 | Substantially Equivalent |
| K110422 | SURGICAL STIMULATORS | May 26, 2011 | Substantially Equivalent |
| K073532 | DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES | May 1, 2008 | Substantially Equivalent |
| K072016 | CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE | Oct 19, 2007 | Substantially Equivalent |
| K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | Aug 21, 2007 | Substantially Equivalent |
| K062437 | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED | Feb 16, 2007 | Substantially Equivalent |