FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OneRF Ablation System
K Number: K231675
·
Decision Dec 6, 2023
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
36
Applicant Total
4
Review Days
181
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Basic Information
- Device Name
- OneRF Ablation System
- K Number
- K231675
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuroone Medical Technologies Corp.
- Date Received
- June 8, 2023
- Decision Date
- December 6, 2023
- Product Code
- GXD
- 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 |
|---|---|---|---|
| GXD | Generator, Lesion, Radiofrequency | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXD), ordered by most recent decision date.
GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
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