K240454
- 510(k) number
- K240454
- Device name
- RESPONDER® Polysaccharide Hemostat
- Applicant
- Starch Medical, Inc. CA · US
- Product code
- QSY — Hemostatic Wound Dressing Without Thrombin Or Other
- Decision date
- 2024-03-15
- Date received
- 2024-02-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K240454.pdf
Official FDA record: K240454
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.