FDA 510(k)

Composite Removable Sinus Stent System

K-Nummer: K170913 · 2017-12-15

Entscheidungsdatum2017-12-15

ProduktcodeLYA

BeratungsausschussEN

EntscheidungSubstantially Equivalent

Produktübersicht

Composite Removable Sinus Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Sts Medical. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K170913. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

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. The listed applicant is Sts Medical. The 510(k) number is K170913.

When did Composite Removable Sinus Stent System receive FDA 510(k) clearance?

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

Who is the listed applicant for Composite Removable Sinus Stent System?

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

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

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

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Verwandte Geräte (Code: LYA)

K243655TurbAlignSpirair, Inc.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLC K202623Novapak Nasensinuskompresse und StentMedtronic Xomed K181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLC

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