Cleared Traditional

K170913 - Composite Removable Sinus Stent System (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K170913 · Sts Medical · Ear, Nose, Throat device
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Dec 2017
Decision
262d
Days
Class 1
Risk

K170913 is an FDA 510(k) clearance for the Composite Removable Sinus Stent System. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Sts Medical (Petah Tikva, IL). The FDA issued a Cleared decision on December 15, 2017 after a review of 262 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K170913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 89d · This submission: 262d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.