K233661
- 510(k) number
- K233661
- Device name
- Transorb Self-Gripping Resorbable Mesh
- Applicant
- Sofradim Production FR
- Product code
- OWT — Mesh, Surgical, Absorbable, Abdominal Hernia
- Decision date
- 2024-02-13
- Date received
- 2023-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233661.pdf
Official FDA record: K233661
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.