K261399
- 510(k) number
- K261399
- Device name
- ELISIO-HX
- Applicant
- Nipro Medical Corporation FL · US
- Product code
- QAX — Hemodialyzer With Expanded Solute Removal Profile
- Decision date
- 2026-07-28
- Date received
- 2026-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261399.pdf
Official FDA record: K261399
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.