K250977
- 510(k) number
- K250977
- Device name
- Suture-TOOL System
- Applicant
- Suturion AB SE
- Product code
- NEW — Suture, Surgical, Absorbable, Polydioxanone
- Decision date
- 2025-04-28
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K250977.pdf
Official FDA record: K250977
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.