FDA 510(k)

SeptAlign (SPLN001)

K-Number: K260620 · 2026-07-30

Decision Date2026-07-30

Product CodeNHB

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

SeptAlign (SPLN001) is the device name listed in this FDA 510(k) record. The listed applicant is Spirair, Inc.. It received FDA 510(k) clearance on 2026-07-30 under 510(k) number K260620. 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 (SPLN001)?

SeptAlign (SPLN001) is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is Spirair, Inc.. The 510(k) number is K260620.

When did SeptAlign (SPLN001) receive FDA 510(k) clearance?

SeptAlign (SPLN001) received FDA 510(k) clearance on 2026-07-30, under 510(k) number K260620.

Who is the listed applicant for SeptAlign (SPLN001)?

The FDA 510(k) record lists Spirair, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SeptAlign (SPLN001)?

The FDA product code for SeptAlign (SPLN001) is NHB.

Other records listing Spirair, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251790SeptAlign K243655TurbAlign K233569SeptAlign K223167Spirair Nasal Septal Strap

Related Devices (Code: NHB)

K251790SeptAlignSpirair, Inc.K233569SeptAlignSpirair, Inc.K223167Spirair Nasal Septal StrapSpirair, Inc.K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLC K192661LATERA Absorbable Nasal Implant SystemEntellus Medical, Inc. (Aka Stryker Ent)K183015PuraSinus3-D Matrix, Inc.

Official Source

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