FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GORE® ENFORM Biomaterial
K Number: K222919
·
Decision Dec 19, 2022
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
7
Applicant Total
3
Review Days
84
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Basic Information
- Device Name
- GORE® ENFORM Biomaterial
- K Number
- K222919
- 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
- W. L. Gore and Associates, Inc.
- Date Received
- September 26, 2022
- Decision Date
- December 19, 2022
- Product Code
- OXF
- 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 |
|---|---|---|---|
| OXF | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | FDA class 2 | General, Plastic Surgery |
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