K243315
- 510(k) number
- K243315
- Device name
- ProGrip Self-Gripping Polypropylene Mesh
- Applicant
- Sofradim Production FR
- Product code
- FTL — Mesh, Surgical, Polymeric
- Decision date
- 2025-01-17
- Date received
- 2024-10-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243315.pdf
Official FDA record: K243315
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.