ELISIO™-HX
FDA 510(k) clearance K261399 · decided 2026-07-28
Clearance details
- K-number
- K261399
- Device name
- ELISIO™-HX
- Applicant
- Nipro Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2026-04-29
- Decision date
- 2026-07-28
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QAX
- Device class
- 2
- Regulation number
- 876.5862
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer (DEN190042) | Baxter Healthcare Corporation | 2020-08-28 |
Recalls involving this device
No recalls on record reference this clearance.