Cleared Special

K121943 - XPRESS MULTI-SINUS DILATION TOOL (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K121943 · Entellus Medical, Inc. · Ear, Nose, Throat device
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Aug 2012
Decision
50d
Days
Class 1
Risk

K121943 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. (Plymouth, US). The FDA issued a Cleared decision on August 22, 2012 after a review of 50 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 K121943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2012
Decision Date August 22, 2012
Days to Decision 50 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
39d faster than avg
Panel avg: 89d · This submission: 50d
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.