K250098
- 510(k) number
- K250098
- Device name
- Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
- Applicant
- Davol, Inc. RI · US
- Product code
- FTL — Mesh, Surgical, Polymeric
- Decision date
- 2025-04-09
- Date received
- 2025-01-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250098.pdf
Official FDA record: K250098
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.