K251955
- 510(k) number
- K251955
- Device name
- Onflex Mesh
- Applicant
- Davol Inc., Subsidiary of C. R. Bard, Inc. RI · US
- Product code
- FTL — Mesh, Surgical, Polymeric
- Decision date
- 2025-07-24
- Date received
- 2025-06-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251955.pdf
Official FDA record: K251955
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.