FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vesta RF Cannula
K Number: K190259
·
Decision Feb 7, 2020
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
65
Applicant Total
2
Review Days
365
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Basic Information
- Device Name
- Vesta RF Cannula
- K Number
- K190259
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4725
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomerics
- Date Received
- February 7, 2019
- Decision Date
- February 7, 2020
- 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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Other Clearances by Biomerics
| K Number | Device Name | ||
|---|---|---|---|
| K121773 | NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE | Sep 21, 2012 | Substantially Equivalent |