Geniant Cranial (Navigated Neurosurgical Positioning Robot) (K241333)
Description
Geniant Cranial (Navigated Neurosurgical Positioning Robot) by KOH YOUNG TECHNOLOGY, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241333
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. Geniant Cranial (Navigated Neurosurgical Positioning Robot) (K241333) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200511 | ROSA ONE Brain application | Medtech S.A | 2020 |
| K162309 | StealthStation S8 System Platforms and StealthStation Crani... | Medtronic Navigation, Inc. | 2017 |
Trace the full predicate network for K241333
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.