FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
K Number: K251505
·
Decision Jul 22, 2025
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
39
Applicant Total
3
Review Days
67
Basic Information
- Device Name
- VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
- K Number
- K251505
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alafair Biosciences
- Date Received
- May 16, 2025
- Decision Date
- July 22, 2025
- Product Code
- JXI
- 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 |
|---|---|---|---|
| JXI | Cuff, Nerve | FDA class 2 | Neurology |
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