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FDA 510(k)

Luja Coude (20108 Male CH18 - large packaging)

K-Number: K233101 · 2023-10-26

ApplicantColoplast Corp.
Decision Date2023-10-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Luja Coude (20108 Male CH18 - large packaging) is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2023-10-26 under approval number K233101. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Luja Coude (20108 Male CH18 - large packaging)?

Luja Coude (20108 Male CH18 - large packaging) is a medical device that received FDA 510(k) clearance on 2023-10-26. It is manufactured by Coloplast Corp.. The 510(k) number is K233101.

When was Luja Coude (20108 Male CH18 - large packaging) approved by the FDA?

Luja Coude (20108 Male CH18 - large packaging) received FDA 510(k) clearance on 2023-10-26, under approval number K233101.

What company makes Luja Coude (20108 Male CH18 - large packaging)?

Luja Coude (20108 Male CH18 - large packaging) is manufactured by Coloplast Corp..

What is the FDA product code for Luja Coude (20108 Male CH18 - large packaging)?

The FDA product code for Luja Coude (20108 Male CH18 - large packaging) is EZD.

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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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