FDA 510(k)

ZeroClear Bag Access (423100)

K-Number: K243976 · 2025-01-22

Decision Date2025-01-22

Product CodeONB

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ZeroClear Bag Access (423100) is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2025-01-22 under approval number K243976. 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 ZeroClear Bag Access (423100)?

ZeroClear Bag Access (423100) is a medical device that received FDA 510(k) clearance on 2025-01-22. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K243976.

When was ZeroClear Bag Access (423100) approved by the FDA?

ZeroClear Bag Access (423100) received FDA 510(k) clearance on 2025-01-22, under approval number K243976.

What company makes ZeroClear Bag Access (423100)?

ZeroClear Bag Access (423100) is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for ZeroClear Bag Access (423100)?

The FDA product code for ZeroClear Bag Access (423100) 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.