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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 the device name listed in this FDA 510(k) record. The listed applicant is Spirair, Inc.. It received FDA 510(k) clearance on 2023-08-17 under 510(k) 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. The listed applicant is Spirair, Inc.. The 510(k) number is K223167.

When did Spirair Nasal Septal Strap receive FDA 510(k) clearance?

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

Who is the listed applicant for Spirair Nasal Septal Strap?

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 Spirair Nasal Septal Strap?

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

Related Clinical Trials

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.

NCT06163404Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair ImplantACTIVE_NOT_RECRUITING

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.

K260620SeptAlign (SPLN001)K251790SeptAlignK243655TurbAlignK233569SeptAlign

Related Devices (Code: NHB)

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.

K260620SeptAlign (SPLN001)Spirair, Inc.K251790SeptAlignSpirair, Inc.K233569SeptAlignSpirair, Inc.K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLCK192661LATERA 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.

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