Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SeptAlign

K-Number: K251790 · 2026-01-16

ApplicantSpirair, Inc.
Decision Date2026-01-16
Product CodeNHB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SeptAlign is a medical device manufactured by Spirair, Inc.. It received FDA 510(k) clearance on 2026-01-16 under approval number K251790. 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 2026-01-16. It is manufactured by Spirair, Inc.. The 510(k) number is K251790.

When was SeptAlign approved by the FDA?

SeptAlign received FDA 510(k) clearance on 2026-01-16, under approval number K251790.

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 K233569SeptAlign K243655TurbAlign

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. K233569SeptAlignSpirair, 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.

↑