Parietene Macroporous Mesh (PPM5050 )— 510(k) K250869
Substantially EquivalentSofradim Production
FDA 510(k) clearance K250869 for Parietene Macroporous Mesh (PPM5050 ), Substantially Equivalent on 2025-04-23. Applicant: Sofradim Production. Device class: 2.
Clearance details
- Applicant
- Sofradim Production
- Product code
- Code FTL
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Trévoux, FR
Recent devices under product code FTL
view allMore clearances from Sofradim Production
view all- K243315 — ProGrip Self-Gripping Polypropylene Mesh
- K233661 — Transorb Self-Gripping Resorbable Mesh
- K232373 — Progrip Self-Gripping Polypropylene Mesh
- K223218 — Parietene Macroporous Mesh
- K220586 — Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
Adverse events under product code FTL
product code FTL- Death
- 317
- Injury
- 66,072
- Malfunction
- 1,273
- Other
- 3
- Total
- 67,665
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.