FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
RF Cannula
K Number: K241367
·
Decision Jan 23, 2025
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
62
Applicant Total
1
Review Days
254
Basic Information
- Device Name
- RF Cannula
- K Number
- K241367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4725
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai SAMedical & Plastic Instruments Co., Ltd.
- Date Received
- May 14, 2024
- Decision Date
- January 23, 2025
- Product Code
- GXI
- 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 |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | FDA class 2 | Neurology |
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