Cleared Special

K141916 - PATHASSIST LED LIGHT FIBER (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K141916 · Entellus Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
23d
Days
Class 1
Risk

K141916 is an FDA 510(k) clearance for the PATHASSIST LED LIGHT FIBER. 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 7, 2014 after a review of 23 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 K141916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2014
Decision Date August 07, 2014
Days to Decision 23 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
66d faster than avg
Panel avg: 89d · This submission: 23d
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.