FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
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)
K Number: K253581
·
Decision Mar 15, 2026
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
42
Applicant Total
13
Review Days
118
Basic Information
- Device Name
- 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)
- K Number
- K253581
- 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
- November 17, 2025
- Decision Date
- March 15, 2026
- 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 |
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|---|---|---|---|
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| K121257 | LARYNGEAL ELECTRODE | Aug 28, 2012 | Substantially Equivalent |
| K110422 | SURGICAL STIMULATORS | May 26, 2011 | Substantially Equivalent |
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| 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 |
| K050325 | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE | May 5, 2005 | Substantially Equivalent |