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FDA 510(k)

ToxiSeal™ Vial Adaptor

K-Number: K241823 · 2024-08-30

ApplicantEpic Medical Pte. , Ltd.
Decision Date2024-08-30
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ToxiSeal™ Vial Adaptor is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2024-08-30 under approval number K241823. 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 ToxiSeal™ Vial Adaptor?

ToxiSeal™ Vial Adaptor is a medical device that received FDA 510(k) clearance on 2024-08-30. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K241823.

When was ToxiSeal™ Vial Adaptor approved by the FDA?

ToxiSeal™ Vial Adaptor received FDA 510(k) clearance on 2024-08-30, under approval number K241823.

What company makes ToxiSeal™ Vial Adaptor?

ToxiSeal™ Vial Adaptor is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for ToxiSeal™ Vial Adaptor?

The FDA product code for ToxiSeal™ Vial Adaptor is ONB.

Other Devices by Epic Medical Pte. , Ltd.

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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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