FDA 510(k)

ProSeal Vented Universal Vial Adaptor

K-Number: K240517 · 2024-12-26

Decision Date2024-12-26

Product CodeONB

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ProSeal Vented Universal Vial Adaptor is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2024-12-26 under approval number K240517. 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 Vented Universal Vial Adaptor?

ProSeal Vented Universal Vial Adaptor is a medical device that received FDA 510(k) clearance on 2024-12-26. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K240517.

When was ProSeal Vented Universal Vial Adaptor approved by the FDA?

ProSeal Vented Universal Vial Adaptor received FDA 510(k) clearance on 2024-12-26, under approval number K240517.

What company makes ProSeal Vented Universal Vial Adaptor?

ProSeal Vented Universal Vial Adaptor is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for ProSeal Vented Universal Vial Adaptor?

The FDA product code for ProSeal Vented Universal Vial Adaptor is ONB.

Other Devices by Epic Medical Pte. , Ltd.

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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.