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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 a medical device manufactured by Excelent, Inc.. It received FDA 510(k) clearance on 2023-05-25 under approval 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. It is manufactured by Excelent, Inc.. The 510(k) number is K230258.

When was BB 8 Sinus Dilation Kit approved by the FDA?

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

What company makes BB 8 Sinus Dilation Kit?

BB 8 Sinus Dilation Kit is manufactured by Excelent, Inc..

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)

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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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