FDA 510(k)

ProSeal Bag Spike with Additive Port (423370ST, 423370)

K-Number: K251340 · 2025-05-29

Decision Date2025-05-29

Product CodeONB

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ProSeal Bag Spike with Additive Port (423370ST, 423370) is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2025-05-29 under approval number K251340. 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 Bag Spike with Additive Port (423370ST, 423370)?

ProSeal Bag Spike with Additive Port (423370ST, 423370) is a medical device that received FDA 510(k) clearance on 2025-05-29. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K251340.

When was ProSeal Bag Spike with Additive Port (423370ST, 423370) approved by the FDA?

ProSeal Bag Spike with Additive Port (423370ST, 423370) received FDA 510(k) clearance on 2025-05-29, under approval number K251340.

What company makes ProSeal Bag Spike with Additive Port (423370ST, 423370)?

ProSeal Bag Spike with Additive Port (423370ST, 423370) is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for ProSeal Bag Spike with Additive Port (423370ST, 423370)?

The FDA product code for ProSeal Bag Spike with Additive Port (423370ST, 423370) is 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.