FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VersaWrap Nerve Protector
K Number: K201631
·
Decision Sep 14, 2020
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
39
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- VersaWrap Nerve Protector
- K Number
- K201631
- 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, Inc.
- Date Received
- June 16, 2020
- Decision Date
- September 14, 2020
- 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 |
Similar 510(k) Clearances
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Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
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Other Clearances by Alafair Biosciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240817 | VersaWrap | Jun 14, 2024 | Substantially Equivalent |
| K232029 | VersaWrap Nerve Protector | Nov 2, 2023 | Substantially Equivalent |
| K213163 | VersaWrap | Oct 29, 2021 | Substantially Equivalent |
| K203600 | VersaWrap | Mar 9, 2021 | Substantially Equivalent |
| K200311 | VersaWrap Tendon Protector | Mar 6, 2020 | Substantially Equivalent |
| K160364 | VersaWrap Tendon Protector | Jun 10, 2016 | Substantially Equivalent |