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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 a medical device manufactured by Coloplast. It received FDA 510(k) clearance on 2024-07-26 under approval 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. It is manufactured by Coloplast. The 510(k) number is K241028.

When was Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) approved by the FDA?

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

What company makes 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 manufactured by Coloplast.

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.

Related Clinical Trials

NCT07376421 Clinical Investigation Exploring a Newly Developed Ostomy Baseplate COMPLETED

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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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