FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Disposable Subdermal Needle Electrode, Corkscrew
K Number: K241045
·
Decision Dec 11, 2024
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
13
Review Days
238
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Basic Information
- Device Name
- Disposable Subdermal Needle Electrode, Corkscrew
- K Number
- K241045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Technomed Europe
- Date Received
- April 17, 2024
- Decision Date
- December 11, 2024
- Product Code
- GXZ
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| GXZ | Electrode, Needle | FDA class 2 | Neurology |
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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 |
| 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 |
| K050325 | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE | May 5, 2005 | Substantially Equivalent |