K253879
- 510(k) number
- K253879
- Device name
- MONOFIX PDO
- Applicant
- Samyang Holdings Corporation KR
- Product code
- NEW — Suture, Surgical, Absorbable, Polydioxanone
- Decision date
- 2026-08-25
- Date received
- 2025-12-04
- 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: K253879.pdf
Official FDA record: K253879
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.