K252047
- 510(k) number
- K252047
- Device name
- STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
- Applicant
- ETHICON, Inc. NJ · US
- Product code
- NEW — Suture, Surgical, Absorbable, Polydioxanone
- Decision date
- 2026-05-18
- Date received
- 2025-06-30
- 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: K252047.pdf
Official FDA record: K252047
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.