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FDA 510(k)

Luja Coude

K-Number: K241210 · 2024-11-21

ApplicantColoplast Corp.
Decision Date2024-11-21
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Luja Coude is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K241210. 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?

Luja Coude is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is Coloplast Corp.. The 510(k) number is K241210.

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

Luja Coude received FDA 510(k) clearance on 2024-11-21, under 510(k) number K241210.

Who is the listed applicant for Luja Coude?

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?

The FDA product code for Luja Coude is EZD.

Other records listing Coloplast Corp. as applicant

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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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