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)— 510(k) K173796

Substantially Equivalent

Sofradim Production

FDA 510(k) clearance K173796 for 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), Substantially Equivalent on 2018-03-09. Applicant: Sofradim Production.

Clearance details

Applicant: Sofradim Production
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2017-12-14
Decision date: 2018-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
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.