Class Class II
ENT EM (K223734)
Description
ENT EM by Brainlab AG, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223734
Clearance Date2023-04-27
Clearance TypeTraditional
Product CodePGW
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223734
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. ENT EM (K223734) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213989 | Cranial EM System | Brainlab AG | 2022 |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT So... | Medtronic Navigation, Inc. | 2020 |
Trace the full predicate network for K223734
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.