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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 the device name listed in this FDA 510(k) record. The listed applicant is Woo Young Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-09-13 under 510(k) 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. The listed applicant is Woo Young Medical Co., Ltd.. The 510(k) number is K210929.

When did MagiCath II receive FDA 510(k) clearance?

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

Who is the listed applicant for MagiCath II?

The FDA 510(k) record lists Woo Young Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagiCath II?

The FDA product code for MagiCath II is FOZ.

Related Devices (Code: FOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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