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FDA 510(k)

TurbAlign

K-Number: K243655 · 2025-07-11

ApplicantSpirair, Inc.
Decision Date2025-07-11
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TurbAlign is a medical device manufactured by Spirair, Inc.. It received FDA 510(k) clearance on 2025-07-11 under approval number K243655. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TurbAlign?

TurbAlign is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Spirair, Inc.. The 510(k) number is K243655.

When was TurbAlign approved by the FDA?

TurbAlign received FDA 510(k) clearance on 2025-07-11, under approval number K243655.

What company makes TurbAlign?

TurbAlign is manufactured by Spirair, Inc..

What is the FDA product code for TurbAlign?

The FDA product code for TurbAlign is LYA.

Other Devices by Spirair, Inc.

K223167Spirair Nasal Septal Strap K233569SeptAlign K251790SeptAlign

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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