K230589
- 510(k) number
- K230589
- Device name
- Celox Rapid X-Ray Gauze
- Applicant
- Medtrade Products , Ltd. GB
- Product code
- QSY — Hemostatic Wound Dressing Without Thrombin Or Other
- Decision date
- 2023-11-17
- Date received
- 2023-03-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230589.pdf
Official FDA record: K230589
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.