Cleared Traditional

K110158 - ILLUMINATING SINUS SEEKER (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K110158 · Entellus Medical, Inc. · Ear, Nose, Throat device
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Jun 2011
Decision
139d
Days
Class 1
Risk

K110158 is an FDA 510(k) clearance for the ILLUMINATING SINUS SEEKER. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Entellus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 7, 2011 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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.

View all Entellus Medical, Inc. devices

Submission Details

510(k) Number K110158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2011
Decision Date June 07, 2011
Days to Decision 139 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
50d slower than avg
Panel avg: 89d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.