Class Class II
NeurAxis IB-Stim (01-1020) (K250451)
Description
NeurAxis IB-Stim (01-1020) by Neuraxis, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250451
Clearance Date2025-05-15
Clearance TypeTraditional
Product CodeQHH
Regulation Number876.5340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250451
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. NeurAxis IB-Stim (01-1020) (K250451) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241533 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2024 |
Trace the full predicate network for K250451
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.