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FDA 510(k)

SINEXUS SINUS STENT GEN 2, MODEL 1999-25

K-Number: K092401 · 2009-11-17

ApplicantSinexus, Inc.
Decision Date2009-11-17
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SINEXUS SINUS STENT GEN 2, MODEL 1999-25 is the device name listed in this FDA 510(k) record. The listed applicant is Sinexus, Inc.. It received FDA 510(k) clearance on 2009-11-17 under 510(k) number K092401. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINEXUS SINUS STENT GEN 2, MODEL 1999-25?

SINEXUS SINUS STENT GEN 2, MODEL 1999-25 is a medical device that received FDA 510(k) clearance on 2009-11-17. The listed applicant is Sinexus, Inc.. The 510(k) number is K092401.

When did SINEXUS SINUS STENT GEN 2, MODEL 1999-25 receive FDA 510(k) clearance?

SINEXUS SINUS STENT GEN 2, MODEL 1999-25 received FDA 510(k) clearance on 2009-11-17, under 510(k) number K092401.

Who is the listed applicant for SINEXUS SINUS STENT GEN 2, MODEL 1999-25?

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

What is the FDA product code for SINEXUS SINUS STENT GEN 2, MODEL 1999-25?

The FDA product code for SINEXUS SINUS STENT GEN 2, MODEL 1999-25 is LYA.

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Related Devices (Code: LYA)

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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.

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