K243241
- 510(k) number
- K243241
- Device name
- Phasix ST Umbilical Hernia Patch
- Applicant
- Davol, Inc., A Subsidiary of C.R. Bard, Inc. RI · US
- Product code
- OWT — Mesh, Surgical, Absorbable, Abdominal Hernia
- Decision date
- 2025-02-19
- Date received
- 2024-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243241.pdf
Official FDA record: K243241
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.