Class Class I
BB 8 Sinus Dilation Kit (K230258)
Description
BB 8 Sinus Dilation Kit by Excelent, Inc., an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK230258
Clearance Date2023-05-25
Clearance TypeTraditional
Product CodeLRC
Regulation Number874.4420
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230258
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. BB 8 Sinus Dilation Kit (K230258) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015 |
| K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015 |
Trace the full predicate network for K230258
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.