FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARIETEX COMPOSITE VENTRAL PATCH
K Number: K120506
·
Decision Jun 13, 2012
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
42
Review Days
113
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Basic Information
- Device Name
- PARIETEX COMPOSITE VENTRAL PATCH
- K Number
- K120506
- 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
- Sofradim Production
- Date Received
- February 21, 2012
- Decision Date
- June 13, 2012
- 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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Other Clearances by Sofradim Production
| K Number | Device Name | ||
|---|---|---|---|
| K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | May 21, 2026 | Substantially Equivalent |
| K250869 | Parietene Macroporous Mesh (PPM5050 ) | Apr 23, 2025 | Substantially Equivalent |
| K243315 | ProGrip Self-Gripping Polypropylene Mesh | Jan 17, 2025 | Substantially Equivalent |
| K233661 | Transorb Self-Gripping Resorbable Mesh | Feb 13, 2024 | Substantially Equivalent |
| K232373 | Progrip Self-Gripping Polypropylene Mesh | Jan 18, 2024 | Substantially Equivalent |
| K223218 | Parietene Macroporous Mesh | Dec 2, 2022 | Substantially Equivalent |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | Jun 22, 2022 | Substantially Equivalent |
| K192443 | Dextile Anatomical Mesh | Dec 6, 2019 | Substantially Equivalent |
| K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) | Mar 9, 2018 | Substantially Equivalent |
| K172395 | Duatene bilayer mesh | Feb 1, 2018 | Substantially Equivalent |