FDA 510(k)

PlazMagik

K-Number: K230837 · 2024-02-29

Decision Date2024-02-29

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PlazMagik is a medical device manufactured by Agnes Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-02-29 under approval number K230837. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PlazMagik?

PlazMagik is a medical device that received FDA 510(k) clearance on 2024-02-29. It is manufactured by Agnes Medical Co., Ltd.. The 510(k) number is K230837.

When was PlazMagik approved by the FDA?

PlazMagik received FDA 510(k) clearance on 2024-02-29, under approval number K230837.

What company makes PlazMagik?

PlazMagik is manufactured by Agnes Medical Co., Ltd..

What is the FDA product code for PlazMagik?

The FDA product code for PlazMagik is GEI.

Other Devices by Agnes Medical Co., Ltd.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.