ELISIO™-HX
K-Number: K261399 · 2026-07-28
Device Summary
Frequently Asked Questions
What is the ELISIO™-HX?
ELISIO™-HX is a medical device that received FDA 510(k) clearance on 2026-07-28. The listed applicant is Nipro Medical Corporation. The 510(k) number is K261399.
When did ELISIO™-HX receive FDA 510(k) clearance?
ELISIO™-HX received FDA 510(k) clearance on 2026-07-28, under 510(k) number K261399.
Who is the listed applicant for ELISIO™-HX?
The FDA 510(k) record lists Nipro Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ELISIO™-HX?
The FDA product code for ELISIO™-HX is QAX.
Other records listing Nipro Medical Corporation as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.