K243595
- 510(k) number
- K243595
- Device name
- OviTex PRS (Long-Term Resorbable)
- Applicant
- TELA Bio, Inc. PA · US
- Product code
- FTM — Mesh, Surgical
- Decision date
- 2024-12-19
- Date received
- 2024-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243595.pdf
Official FDA record: K243595
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.