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FDA 510(k)

Luja Coude (20108 Male CH18 - large packaging)

K-Number: K233101 · 2023-10-26

Decision Date2023-10-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Luja Coude (20108 Male CH18 - large packaging) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2023-10-26 under 510(k) 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. The listed applicant is Coloplast Corp.. The 510(k) number is K233101.

When did Luja Coude (20108 Male CH18 - large packaging) receive FDA 510(k) clearance?

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

Who is the listed applicant for Luja Coude (20108 Male CH18 - large packaging)?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Coloplast Corp. 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.

View all 42 devices →

Related Devices (Code: EZD)

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.

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.