FDA 510(k)

ProSeal Injector Plus (Model no. 421050)

K-Number: K240171 · 2024-03-28

Decision Date2024-03-28

Product CodeONB

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ProSeal Injector Plus (Model no. 421050) is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2024-03-28 under approval number K240171. 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 Injector Plus (Model no. 421050)?

ProSeal Injector Plus (Model no. 421050) is a medical device that received FDA 510(k) clearance on 2024-03-28. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K240171.

When was ProSeal Injector Plus (Model no. 421050) approved by the FDA?

ProSeal Injector Plus (Model no. 421050) received FDA 510(k) clearance on 2024-03-28, under approval number K240171.

What company makes ProSeal Injector Plus (Model no. 421050)?

ProSeal Injector Plus (Model no. 421050) is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for ProSeal Injector Plus (Model no. 421050)?

The FDA product code for ProSeal Injector Plus (Model no. 421050) 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.