Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh— 510(k) K142908

Substantially Equivalent

Sofradim Production

FDA 510(k) clearance K142908 for Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh, Substantially Equivalent on 2014-11-14. Applicant: Sofradim Production.

Clearance details

Applicant: Sofradim Production
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2014-10-06
Decision date: 2014-11-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Trévoux, FR

Download summary PDF View on FDA.gov ↗

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.