K253125
- 510(k) number
- K253125
- Device name
- Parietene Flat Sheet Mesh
- Applicant
- Medtronic - Sofradim Production FR
- Product code
- FTL — Mesh, Surgical, Polymeric
- Decision date
- 2025-10-24
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K253125.pdf
Official FDA record: K253125
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.