Composite Removable Sinus Stent System— 510(k) K170913

Name: FDA 510(k) clearance K170913
Creator: U.S. Food and Drug Administration
Published: 2017-12-15

Substantially Equivalent

Sts Medical

FDA 510(k) clearance K170913 for Composite Removable Sinus Stent System, Substantially Equivalent on 2017-12-15. Applicant: Sts Medical. Device class: 1.

Clearance details

Applicant: Sts Medical
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2017-03-28
Decision date: 2017-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petah Tikva, IL

Download summary PDF View on FDA.gov ↗

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