eZSURE Empty Fluid Container
K-Number: K252094 · 2025-08-01
ApplicantEpic Medical Pte. , Ltd.
Decision Date2025-08-01
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
eZSURE Empty Fluid Container is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2025-08-01 under approval number K252094. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the eZSURE Empty Fluid Container?
eZSURE Empty Fluid Container is a medical device that received FDA 510(k) clearance on 2025-08-01. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K252094.
When was eZSURE Empty Fluid Container approved by the FDA?
eZSURE Empty Fluid Container received FDA 510(k) clearance on 2025-08-01, under approval number K252094.
What company makes eZSURE Empty Fluid Container?
eZSURE Empty Fluid Container is manufactured by Epic Medical Pte. , Ltd..
What is the FDA product code for eZSURE Empty Fluid Container?
The FDA product code for eZSURE Empty Fluid Container is KPE.
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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.