Class Class II
Luja Set (K250270)
Description
Luja Set by Coloplast Corp., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250270
Clearance Date2025-04-17
Clearance TypeSpecial
Product CodeEZD
Regulation Number876.5130
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250270
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Luja Set (K250270) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2025 |
| K241210 | Luja Coude | Coloplast Corp. | 2024 |
| K222059 | SpeediCath Flex Set | Coloplast | 2022 |
Trace the full predicate network for K250270
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.