K250598
- 510(k) number
- K250598
- Device name
- Endoform Reconstructive Template - PLGA
- Applicant
- Aroa Biosurgery , Ltd. NZ
- Product code
- FTM — Mesh, Surgical
- Decision date
- 2025-06-03
- Date received
- 2025-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250598.pdf
Official FDA record: K250598
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.