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FDA 510(k)

MagiCath II

K-Number: K210929 · 2022-09-13

ApplicantWoo Young Medical Co., Ltd.
Decision Date2022-09-13
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MagiCath II is a medical device manufactured by Woo Young Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-09-13 under approval number K210929. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MagiCath II?

MagiCath II is a medical device that received FDA 510(k) clearance on 2022-09-13. It is manufactured by Woo Young Medical Co., Ltd.. The 510(k) number is K210929.

When was MagiCath II approved by the FDA?

MagiCath II received FDA 510(k) clearance on 2022-09-13, under approval number K210929.

What company makes MagiCath II?

MagiCath II is manufactured by Woo Young Medical Co., Ltd..

What is the FDA product code for MagiCath II?

The FDA product code for MagiCath II is FOZ.

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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.

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