Class Class II
ClearPoint System (Software Version 3.0) (K243657)
Description
ClearPoint System (Software Version 3.0) by ClearPoint Neuro, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243657
Clearance Date2025-01-24
Clearance TypeTraditional
Product CodeHAW
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243657
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. ClearPoint System (Software Version 3.0) (K243657) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | 2023 |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | 2023 |
| K222519 | ClearPoint System | ClearPoint Neuro, Inc. | 2022 |
Trace the full predicate network for K243657
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.