K252743
- 510(k) number
- K252743
- Device name
- STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- Applicant
- ETHICON, Inc. NJ · US
- Product code
- GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
- Decision date
- 2025-12-22
- Date received
- 2025-08-28
- 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: K252743.pdf
Official FDA record: K252743
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.