Class Class II
JMS CAVEO A.V. Fistula Needle Set (K251877)
Description
JMS CAVEO A.V. Fistula Needle Set by JMS North America Corporation, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251877
Clearance Date2025-08-15
Clearance TypeTraditional
Product CodeFIE
Regulation Number876.5540
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251877
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. JMS CAVEO A.V. Fistula Needle Set (K251877) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MI... | JMS North America Corporation | 2014 |
| K111948 | WINGEATER V2 | JMS North America Corporation | 2011 |
Trace the full predicate network for K251877
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.