FDA 510(k)

eZSURE Empty Fluid Container with ProSeal Injection Site

K-Number: K241442 · 2024-06-21

Decision Date2024-06-21

Product CodeKPE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

eZSURE Empty Fluid Container with ProSeal Injection Site is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2024-06-21 under approval number K241442. 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 with ProSeal Injection Site?

eZSURE Empty Fluid Container with ProSeal Injection Site is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K241442.

When was eZSURE Empty Fluid Container with ProSeal Injection Site approved by the FDA?

eZSURE Empty Fluid Container with ProSeal Injection Site received FDA 510(k) clearance on 2024-06-21, under approval number K241442.

What company makes eZSURE Empty Fluid Container with ProSeal Injection Site?

eZSURE Empty Fluid Container with ProSeal Injection Site is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for eZSURE Empty Fluid Container with ProSeal Injection Site?

The FDA product code for eZSURE Empty Fluid Container with ProSeal Injection Site is KPE.

Related Clinical Trials

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Other Devices by Epic Medical Pte. , Ltd.

K151650SMARTez elastomeric infusion pump K192075ProSeal Closed System drug Transfer Device (CSTD) K201626Safety Subcutaneous Infusion Set K230343ProSeal Closed System Administration Set K223674eZSURE Empty Fluid Container (models 426030, 426040, 426110) K240517ProSeal Vented Universal Vial Adaptor

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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.