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FDA 510(k)

SeptAlign

K-Number: K233569 · 2024-03-22

ApplicantSpirair, Inc.
Decision Date2024-03-22
Product CodeNHB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SeptAlign is a medical device manufactured by Spirair, Inc.. It received FDA 510(k) clearance on 2024-03-22 under approval number K233569. The device is classified under product code NHB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeptAlign?

SeptAlign is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Spirair, Inc.. The 510(k) number is K233569.

When was SeptAlign approved by the FDA?

SeptAlign received FDA 510(k) clearance on 2024-03-22, under approval number K233569.

What company makes SeptAlign?

SeptAlign is manufactured by Spirair, Inc..

What is the FDA product code for SeptAlign?

The FDA product code for SeptAlign is NHB.

Other Devices by Spirair, Inc.

K223167Spirair Nasal Septal Strap K243655TurbAlign K251790SeptAlign

Related Devices (Code: NHB)

K161191Latera Absorbable Nasal ImplantSpirox, Inc. K192661LATERA Absorbable Nasal Implant SystemEntellus Medical, Inc. (Aka Stryker Ent) K183015PuraSinus3-D Matrix, Inc. K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLC K223167Spirair Nasal Septal StrapSpirair, Inc. K251790SeptAlignSpirair, Inc.

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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