ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)— 510(k) K253956
Substantially EquivalentSofradim Production
FDA 510(k) clearance K253956 for ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030), Substantially Equivalent on 2026-05-21. Applicant: Sofradim Production. Device class: 2.
Summary
Sofradim Production's ProGrip advanced self-gripping polypropylene mesh lists four model numbers (ADG1510, ADG2015, ADG3020, ADG4030) and is filed under FTL, polymeric surgical meshes.
Class II, 21 CFR 878.3300. General and Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
Sofradim filed from Trévoux, France. Review took 162 calendar days (December 10, 2025 to May 21, 2026).
Clearance details
- Applicant
- Sofradim Production
- Product code
- Product 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
- Traditional
- 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.