Class Class II
PATI (Protector Against Tongue Injury) (K221469)
Description
PATI (Protector Against Tongue Injury) by Neurovice, LLC, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221469
Clearance Date2023-02-22
Clearance TypeTraditional
Product CodeJXL
Regulation Number882.5070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221469
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. PATI (Protector Against Tongue Injury) (K221469) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172978 | SurgeoBite | Surgovations, LLC | 2017 |
Trace the full predicate network for K221469
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.