Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

eZSURE™ Empty Fluid Container with ProSeal™ Injection Site

K-Number: K241442 · 2024-06-21

ApplicantEpic Medical Pte. , Ltd.
Decision Date2024-06-21
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

eZSURE™ Empty Fluid Container with ProSeal™ Injection Site 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 2024-06-21 under 510(k) 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. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K241442.

When did eZSURE™ Empty Fluid Container with ProSeal™ Injection Site receive FDA 510(k) clearance?

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

Who is the listed applicant for eZSURE™ Empty Fluid Container with ProSeal™ Injection Site?

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 with ProSeal™ Injection Site?

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

Related Clinical Trials

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.

NCT06611098New Treatment of Knee OsteoarthritisCOMPLETEDNCT07079397Hyaluronic Acid Filler MigrationACTIVE_NOT_RECRUITING

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 DeviceK250234SMARTeZ™ Elastomeric Infusion Pump (RS series)K251722ProSeal™ Transfer Injector (421120, 421130, 421140)K251814EZ™ IV Administration SetK252094eZSURE™ Empty Fluid ContainerK251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

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.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ 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.K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic 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.

↑