Class Class II
APEX 6 (K220122)
Description
APEX 6 by Rf Innovations, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220122
Clearance Date2023-03-15
Clearance TypeTraditional
Product CodeGXD
Regulation Number882.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220122
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. APEX 6 (K220122) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191293 | LCCS VC-S RF Cannula | Lccs Products Limited | 2020 |
| K111576 | NT 2000 LESIONING GENERATOR | Neuro Therm, Inc. | 2011 |
Trace the full predicate network for K220122
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.