K252171
- 510(k) number
- K252171
- Device name
- Barbed PDO Suture
- Applicant
- Sutura Medical Technology, Inc. MA · US
- Product code
- NEW — Suture, Surgical, Absorbable, Polydioxanone
- Decision date
- 2026-06-12
- Date received
- 2025-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252171.pdf
Official FDA record: K252171
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.