K260533
- 510(k) number
- K260533
- Device name
- ELISIO-H
- Applicant
- Nipro Medical Corporation FL · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2026-03-19
- Date received
- 2026-02-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K260533.pdf
Official FDA record: K260533
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.