FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Medical Disposable Sterile Needle Electrode
K Number: K232581
·
Decision Dec 4, 2023
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
2
Review Days
101
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
- Medical Disposable Sterile Needle Electrode
- K Number
- K232581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suzhou Haishen Medical Device Associates Co., Ltd.
- Date Received
- August 25, 2023
- Decision Date
- December 4, 2023
- 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
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
DMS Disposable Subdermal Needle Electrodes
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Suzhou Haishen Medical Device Associates Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232888 | Disposable Laryngeal Electrodes | Dec 21, 2023 | Substantially Equivalent |