Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh— 510(k) K220586

Substantially Equivalent

Sofradim Production

FDA 510(k) clearance K220586 for Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh, Substantially Equivalent on 2022-06-22. Applicant: Sofradim Production.

Clearance details

Applicant: Sofradim Production
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2022-03-01
Decision date: 2022-06-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Trévoux, FR

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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, 2020-01-01 through 2026-04-23. 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.