FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
NEOVEIL Staple Line Reinforcement
K Number: K221487
·
Decision Aug 26, 2022
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
8
Applicant Total
5
Review Days
95
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Basic Information
- Device Name
- NEOVEIL Staple Line Reinforcement
- K Number
- K221487
- 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
- Gunze Limited
- Date Received
- May 23, 2022
- Decision Date
- August 26, 2022
- Product Code
- OXC
- 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 |
|---|---|---|---|
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | FDA class 2 | General, Plastic Surgery |
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