ELISIO-H
K-Number: K260533 · 2026-03-19
ApplicantNipro Medical Corporation
Decision Date2026-03-19
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ELISIO-H is a medical device manufactured by Nipro Medical Corporation. It received FDA 510(k) clearance on 2026-03-19 under approval number K260533. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ELISIO-H?
ELISIO-H is a medical device that received FDA 510(k) clearance on 2026-03-19. It is manufactured by Nipro Medical Corporation. The 510(k) number is K260533.
When was ELISIO-H approved by the FDA?
ELISIO-H received FDA 510(k) clearance on 2026-03-19, under approval number K260533.
What company makes ELISIO-H?
ELISIO-H is manufactured by Nipro Medical Corporation.
What is the FDA product code for ELISIO-H?
The FDA product code for ELISIO-H is KDI.
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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.