FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
K Number: K050325
·
Decision May 5, 2005
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
13
Review Days
85
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
- K Number
- K050325
- 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
- February 9, 2005
- Decision Date
- May 5, 2005
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXZ), ordered by most recent decision date.
Disposable Subdermal Needle Electrode, Corkscrew
FDA 510(k)
FDA Class 2
·Neurology
Medical Disposable Sterile Needle Electrode
FDA 510(k)
FDA Class 2
·Neurology
Phantom XL Insulated Dilators
FDA 510(k)
FDA Class 2
·Neurology
Guardian Needle Electrode
FDA 510(k)
FDA Class 2
·Neurology
Spes Medica Subdermal Needle Electrodes
FDA 510(k)
FDA Class 2
·Neurology
PressOn Electrode Headset
FDA 510(k)
FDA Class 2
·Neurology
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 |