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FDA 510(k)

Composite Removable Sinus Stent System

K-Number: K170913 · 2017-12-15

ApplicantSts Medical
Decision Date2017-12-15
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Composite Removable Sinus Stent System is a medical device manufactured by Sts Medical. It received FDA 510(k) clearance on 2017-12-15 under approval number K170913. 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 Composite Removable Sinus Stent System?

Composite Removable Sinus Stent System is a medical device that received FDA 510(k) clearance on 2017-12-15. It is manufactured by Sts Medical. The 510(k) number is K170913.

When was Composite Removable Sinus Stent System approved by the FDA?

Composite Removable Sinus Stent System received FDA 510(k) clearance on 2017-12-15, under approval number K170913.

What company makes Composite Removable Sinus Stent System?

Composite Removable Sinus Stent System is manufactured by Sts Medical.

What is the FDA product code for Composite Removable Sinus Stent System?

The FDA product code for Composite Removable Sinus Stent System is LYA.

Related Clinical Trials

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Related PubMed Literature

PMID: 25262248 Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration. American heart journal (2014)

Related Devices (Code: LYA)

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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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