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FDA 510(k)

Relieva Scout Multi-Sinus Dilation System

K-Number: K153341 · 2016-02-12

Decision Date2016-02-12
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Relieva Scout Multi-Sinus Dilation System is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2016-02-12 under approval number K153341. 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 Relieva Scout Multi-Sinus Dilation System?

Relieva Scout Multi-Sinus Dilation System is a medical device that received FDA 510(k) clearance on 2016-02-12. It is manufactured by Acclarent, Inc.. The 510(k) number is K153341.

When was Relieva Scout Multi-Sinus Dilation System approved by the FDA?

Relieva Scout Multi-Sinus Dilation System received FDA 510(k) clearance on 2016-02-12, under approval number K153341.

What company makes Relieva Scout Multi-Sinus Dilation System?

Relieva Scout Multi-Sinus Dilation System is manufactured by Acclarent, Inc..

What is the FDA product code for Relieva Scout Multi-Sinus Dilation System?

The FDA product code for Relieva Scout Multi-Sinus Dilation System is LRC.

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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.