FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VersaWrap
K Number: K240817
·
Decision Jun 14, 2024
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
9
Applicant Total
7
Review Days
81
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Basic Information
- Device Name
- VersaWrap
- K Number
- K240817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alafair Biosciences, Inc.
- Date Received
- March 25, 2024
- Decision Date
- June 14, 2024
- Product Code
- OWW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| OWW | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OWW), ordered by most recent decision date.
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Other Clearances by Alafair Biosciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232029 | VersaWrap Nerve Protector | Nov 2, 2023 | Substantially Equivalent |
| K213163 | VersaWrap | Oct 29, 2021 | 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 |