FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ProGrip Self-Gripping Polypropylene Mesh
K Number: K220540
·
Decision Sep 22, 2022
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
130
Review Days
209
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Basic Information
- Device Name
- ProGrip Self-Gripping Polypropylene Mesh
- K Number
- K220540
- 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
- Covidien
- Date Received
- February 25, 2022
- Decision Date
- September 22, 2022
- Product Code
- FTL
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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