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FDA 510(k)

eZSURE™ Empty Fluid Container

K-Number: K252094 · 2025-08-01

Decision Date2025-08-01
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

eZSURE™ Empty Fluid Container is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) 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. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K252094.

When did eZSURE™ Empty Fluid Container receive FDA 510(k) clearance?

eZSURE™ Empty Fluid Container received FDA 510(k) clearance on 2025-08-01, under 510(k) number K252094.

Who is the listed applicant for eZSURE™ Empty Fluid Container?

The FDA 510(k) record lists Epic Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eZSURE™ Empty Fluid Container?

The FDA product code for eZSURE™ Empty Fluid Container is KPE.

Other records listing Epic Medical Pte. , Ltd. 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.

View all 22 devices →

Related Devices (Code: KPE)

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.