K241126
- 510(k) number
- K241126
- Device name
- OviTex PRS
- Applicant
- TELA Bio, Inc. PA · US
- Product code
- FTM — Mesh, Surgical
- Decision date
- 2024-05-22
- Date received
- 2024-04-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241126.pdf
Official FDA record: K241126
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.