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FDA 510(k)

Luja Coudé

K-Number: K251116 · 2025-06-27

ApplicantColoplast Corp.
Decision Date2025-06-27
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Luja Coudé is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K251116. 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 Coudé?

Luja Coudé is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Coloplast Corp.. The 510(k) number is K251116.

When did Luja Coudé receive FDA 510(k) clearance?

Luja Coudé received FDA 510(k) clearance on 2025-06-27, under 510(k) number K251116.

Who is the listed applicant for Luja Coudé?

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 Coudé?

The FDA product code for Luja Coudé is EZD.

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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.

K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister IncorporatedK260999LoFric Elle ProWellspect AB

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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