ELISIO-HX— 510(k) K261399

Substantially Equivalent

Nipro Medical Corporation

FDA 510(k) clearance K261399 for ELISIO-HX, Substantially Equivalent on 2026-07-28. Applicant: Nipro Medical Corporation. Device class: 2.

Clearance details

Applicant: Nipro Medical Corporation
Product code: Code QAX
Device class: Class 2
Regulation: 21 CFR 876.5862
Advisory panel: Gastroenterology, Urology
Date received: 2026-04-29
Decision date: 2026-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QAX

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K212677 — aboNT SYRINGE2022-04-15
K190037 — Cronus HP PTA Balloon Catheter2019-10-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.