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FDA 510(k)

BB 8 Sinus Dilation Kit

K-Number: K230258 · 2023-05-25

ApplicantExcelent, Inc.
Decision Date2023-05-25
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BB 8 Sinus Dilation Kit is the device name listed in this FDA 510(k) record. The listed applicant is Excelent, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K230258. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BB 8 Sinus Dilation Kit?

BB 8 Sinus Dilation Kit is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Excelent, Inc.. The 510(k) number is K230258.

When did BB 8 Sinus Dilation Kit receive FDA 510(k) clearance?

BB 8 Sinus Dilation Kit received FDA 510(k) clearance on 2023-05-25, under 510(k) number K230258.

Who is the listed applicant for BB 8 Sinus Dilation Kit?

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

What is the FDA product code for BB 8 Sinus Dilation Kit?

The FDA product code for BB 8 Sinus Dilation Kit is LRC.

Related Devices (Code: LRC)

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.

K212774VenSure LightGuideIntersect Ent.K201398SINUSPRIME Dilation SystemStryker EntK201115Next Generation Balloon Dilation SystemAcclarent, Inc.K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbHK181546Dillard Nasal Balloon CatheterIntuit Medical Products, LLCK190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, 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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