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FDA 510(k)

ProSeal™ Closed System Bag Access

K-Number: K241988 · 2024-10-23

ApplicantEpic Medical Pte. , Ltd.
Decision Date2024-10-23
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ProSeal™ Closed System Bag Access is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2024-10-23 under approval number K241988. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProSeal™ Closed System Bag Access?

ProSeal™ Closed System Bag Access is a medical device that received FDA 510(k) clearance on 2024-10-23. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K241988.

When was ProSeal™ Closed System Bag Access approved by the FDA?

ProSeal™ Closed System Bag Access received FDA 510(k) clearance on 2024-10-23, under approval number K241988.

What company makes ProSeal™ Closed System Bag Access?

ProSeal™ Closed System Bag Access is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for ProSeal™ Closed System Bag Access?

The FDA product code for ProSeal™ Closed System Bag Access is ONB.

Related Clinical Trials

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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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Related Devices (Code: ONB)

K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical , Ltd. K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant K181221BD PhaSeal Optima Closed System Transfer DeviceBecton, Dickinson and Company K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc. K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial AdaptorJ & J Solutions, Inc. D/B/A/ Corvida Medical

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.

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