FDA 510(k)

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)

K-Number: K223674 · 2023-09-01

Decision Date2023-09-01

Product CodeKPE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) 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 2023-09-01 under 510(k) number K223674. 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 (models 426030, 426040, 426110)?

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K223674.

When did eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) receive FDA 510(k) clearance?

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) received FDA 510(k) clearance on 2023-09-01, under 510(k) number K223674.

Who is the listed applicant for eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)?

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 (models 426030, 426040, 426110)?

The FDA product code for eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) 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.

K252987ADRx™ Admixture Device K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)K251722ProSeal™ Transfer Injector (421120, 421130, 421140)K251814EZ™ IV Administration Set K252094eZSURE™ Empty Fluid Container K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

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Related Devices (Code: KPE)

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG K252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.

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.