K253290
- 510(k) number
- K253290
- Device name
- XSTAT P15
- Applicant
- Revmedx, Inc. OR · US
- Product code
- PGZ — Non-Absorbable, Expandable, Hemostatic Sponge For Te
- Decision date
- 2025-11-12
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K253290.pdf
Official FDA record: K253290
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.