Cleared Special

K112506 - XPRESS MULTI-SINUS DILATION TOOL (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K112506 · Entellus Medical, Inc. · Ear, Nose, Throat device
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Dec 2011
Decision
113d
Days
Class 1
Risk

K112506 is an FDA 510(k) clearance for the XPRESS MULTI-SINUS DILATION TOOL. 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 December 21, 2011 after a review of 113 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Entellus Medical, Inc. devices

Submission Details

510(k) Number K112506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2011
Decision Date December 21, 2011
Days to Decision 113 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 89d · This submission: 113d
Pathway characteristics
Modification to existing cleared device.

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.