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FDA 510(k)

Spirair Nasal Septal Strap

K-Number: K223167 · 2023-08-17

ApplicantSpirair, Inc.
Decision Date2023-08-17
Product CodeNHB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Spirair Nasal Septal Strap is a medical device manufactured by Spirair, Inc.. It received FDA 510(k) clearance on 2023-08-17 under approval number K223167. 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 Spirair Nasal Septal Strap?

Spirair Nasal Septal Strap is a medical device that received FDA 510(k) clearance on 2023-08-17. It is manufactured by Spirair, Inc.. The 510(k) number is K223167.

When was Spirair Nasal Septal Strap approved by the FDA?

Spirair Nasal Septal Strap received FDA 510(k) clearance on 2023-08-17, under approval number K223167.

What company makes Spirair Nasal Septal Strap?

Spirair Nasal Septal Strap is manufactured by Spirair, Inc..

What is the FDA product code for Spirair Nasal Septal Strap?

The FDA product code for Spirair Nasal Septal Strap is NHB.

Related Clinical Trials

NCT06163404 Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant ACTIVE_NOT_RECRUITING

Other Devices by Spirair, Inc.

K233569SeptAlign 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 K233569SeptAlignSpirair, 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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