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FDA 510(k)

ToxiSeal Vial Adapter with External Balloon

K-Number: K222929 · 2024-01-11

ApplicantEpic Medical Pte. , Ltd.
Decision Date2024-01-11
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ToxiSeal Vial Adapter with External Balloon is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2024-01-11 under approval number K222929. 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 Adapter with External Balloon?

ToxiSeal Vial Adapter with External Balloon is a medical device that received FDA 510(k) clearance on 2024-01-11. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K222929.

When was ToxiSeal Vial Adapter with External Balloon approved by the FDA?

ToxiSeal Vial Adapter with External Balloon received FDA 510(k) clearance on 2024-01-11, under approval number K222929.

What company makes ToxiSeal Vial Adapter with External Balloon?

ToxiSeal Vial Adapter with External Balloon is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for ToxiSeal Vial Adapter with External Balloon?

The FDA product code for ToxiSeal Vial Adapter with External Balloon is ONB.

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Related Devices (Code: ONB)

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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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