K253572
- 510(k) number
- K253572
- Device name
- STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- Applicant
- ETHICON, Inc. NJ · US
- Product code
- GAW — Suture, Nonabsorbable, Synthetic, Polypropylene
- Decision date
- 2026-03-27
- Date received
- 2025-11-17
- 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: K253572.pdf
Official FDA record: K253572
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.