FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VersaWrap
K Number: K213163
·
Decision Oct 29, 2021
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
7
Review Days
31
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Basic Information
- Device Name
- VersaWrap
- K Number
- K213163
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alafair Biosciences, Inc.
- Date Received
- September 28, 2021
- Decision Date
- October 29, 2021
- Product Code
- FTM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
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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 |
| K203600 | VersaWrap | Mar 9, 2021 | Substantially Equivalent |
| K201631 | VersaWrap Nerve Protector | Sep 14, 2020 | Substantially Equivalent |
| K200311 | VersaWrap Tendon Protector | Mar 6, 2020 | Substantially Equivalent |
| K160364 | VersaWrap Tendon Protector | Jun 10, 2016 | Substantially Equivalent |