Class Class I
TurbAlign (K243655)
Description
TurbAlign by Spirair, Inc., an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK243655
Clearance Date2025-07-11
Clearance TypeTraditional
Product CodeLYA
Regulation Number874.4780
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243655
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. TurbAlign (K243655) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | 2023 |
| K130354 | MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR... | Entrigue Surgical, Inc. | 2013 |
Trace the full predicate network for K243655
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.