Transorb Self-Gripping Resorbable Mesh— 510(k) K233661

Substantially Equivalent

Sofradim Production

FDA 510(k) clearance K233661 for Transorb Self-Gripping Resorbable Mesh, Substantially Equivalent on 2024-02-13. Applicant: Sofradim Production.

Clearance details

Applicant: Sofradim Production
Product code: Code OWT
Advisory panel: General, Plastic Surgery
Date received: 2023-11-15
Decision date: 2024-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trévoux, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWT

product code OWT

Death: 3
Injury: 396
Total: 399

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.