Cleared Traditional

Composite Removable Sinus Stent System

K170913 · Sts Medical · Ear, Nose, Throat

Dec 2017

Decision

262d

Days

Class 1

Risk

About This 510(k) Submission

K170913 is an FDA 510(k) clearance for the Composite Removable Sinus Stent System, a Splint, Intranasal Septal (Class I — General Controls, product code LYA), submitted by Sts Medical (Petah Tikva, IL). The FDA issued a Cleared decision on December 15, 2017, 262 days after receiving the submission on March 28, 2017. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number	K170913 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2017
Decision Date	December 15, 2017
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF