K242835
- 510(k) number
- K242835
- Device name
- Suture-TOOL System
- Applicant
- Suturion AB SE
- Product code
- NEW — Suture, Surgical, Absorbable, Polydioxanone
- Decision date
- 2025-01-22
- Date received
- 2024-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242835.pdf
Official FDA record: K242835
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.