Class Class II
TalisMann Neuromodulation System (K243678)
Description
TalisMann Neuromodulation System by Bioventus, LLC, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243678
Clearance Date2025-07-03
Clearance TypeTraditional
Product CodeGZF
Regulation Number882.5870
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243678
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. TalisMann Neuromodulation System (K243678) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211965 | StimRouter Neuromodulation System | Bioness, Inc. | 2022 |
| K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual... | Boston Scientific Neuromodulation | 2019 |
Trace the full predicate network for K243678
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.