Luja Set
K-Number: K250270 · 2025-04-17
ApplicantColoplast Corp.
Decision Date2025-04-17
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Luja Set is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2025-04-17 under approval number K250270. 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 Set?
Luja Set is a medical device that received FDA 510(k) clearance on 2025-04-17. It is manufactured by Coloplast Corp.. The 510(k) number is K250270.
When was Luja Set approved by the FDA?
Luja Set received FDA 510(k) clearance on 2025-04-17, under approval number K250270.
What company makes Luja Set?
Luja Set is manufactured by Coloplast Corp..
What is the FDA product code for Luja Set?
The FDA product code for Luja Set is EZD.
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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.