Medical Device Manufacturer · US , San Jose , CA

Spirair, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2023

Recent clearances: SeptAlign, TurbAlign, SeptAlign

4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - Spirair, Inc. Ear, Nose, Throat ✕

4 devices
1-4 of 4
Cleared Jan 16, 2026
SeptAlign
K251790 · NHB
Ear, Nose, Throat · 219d
Cleared Jul 11, 2025
TurbAlign
K243655 · LYA
Ear, Nose, Throat · 227d
Cleared Mar 22, 2024
SeptAlign
K233569 · NHB
Ear, Nose, Throat · 137d
Cleared Aug 17, 2023
Spirair Nasal Septal Strap
K223167 · NHB
Ear, Nose, Throat · 314d
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