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FDA 510(k)

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)

K-Number: K241028 · 2024-07-26

ApplicantColoplast
Decision Date2024-07-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K241028. 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 female (20051); Luja female (20052); Luja female (20054); Luja female (20056)?

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Coloplast. The 510(k) number is K241028.

When did Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) receive FDA 510(k) clearance?

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) received FDA 510(k) clearance on 2024-07-26, under 510(k) number K241028.

Who is the listed applicant for Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)?

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

What is the FDA product code for Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)?

The FDA product code for Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) is EZD.

Other records listing Coloplast 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.

PMA P000006Device, impotence, mechanical/hydraulicPMA P020003Prosthesis, testicularK252140Heylo™ SystemK251116Luja CoudéK250270Luja SetK242049SureCath Set

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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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