FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OviTex PRS (Long Term Resorbable)
K Number: K214070
·
Decision Mar 21, 2023
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
1
Review Days
449
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Basic Information
- Device Name
- OviTex PRS (Long Term Resorbable)
- K Number
- K214070
- 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
- Tela Bio
- Date Received
- December 27, 2021
- Decision Date
- March 21, 2023
- 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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