Class Class II
CIONIC NEURAL SLEEVE (NS-200) (K243828)
Description
CIONIC NEURAL SLEEVE (NS-200) by Cionic, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243828
Clearance Date2025-05-02
Clearance TypeTraditional
Product CodeGZI
Regulation Number882.5810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243828
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. CIONIC NEURAL SLEEVE (NS-200) (K243828) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221823 | Cionic Neural Sleeve NS-100 | Cionic | 2022 |
| K080950 | STIWELL MED4 | Otto Bock, Austria GmbH | 2009 |
Trace the full predicate network for K243828
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.