510(k) K991400— PARIETENE POLYPROPYLENE MESH

Substantially Equivalent

Sofradim Production

Clearance details

Applicant: Sofradim Production
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 1999-04-22
Decision date: 1999-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer, MA, US

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.