Class Class II
Veloxion System (K230205)
Description
Veloxion System by Corinth Medtech, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230205
Clearance Date2023-02-24
Clearance TypeSpecial
Product CodeFJL
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230205
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. Veloxion System (K230205) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxi... | Corinth Medtech, Inc. | 2019 |
Trace the full predicate network for K230205
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.