FDA 510(k)

Zircos-Com

K-Number: K190139 · 2020-04-24

Decision Date2020-04-24

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Zircos-Com is the device name listed in this FDA 510(k) record. The listed applicant is Bioden Co., Ltd.. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K190139. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zircos-Com?

Zircos-Com is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Bioden Co., Ltd.. The 510(k) number is K190139.

When did Zircos-Com receive FDA 510(k) clearance?

Zircos-Com received FDA 510(k) clearance on 2020-04-24, under 510(k) number K190139.

Who is the listed applicant for Zircos-Com?

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

What is the FDA product code for Zircos-Com?

The FDA product code for Zircos-Com is EBF.

Other records listing Bioden Co., Ltd. as applicant

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.