K240097
- 510(k) number
- K240097
- Device name
- Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
- Applicant
- Ushare Medical, Inc. CN
- Product code
- QSY — Hemostatic Wound Dressing Without Thrombin Or Other
- Decision date
- 2024-05-22
- Date received
- 2024-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240097.pdf
Official FDA record: K240097
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.