Cleared Special

K160171 - Illuminated Mediastinal Access Port (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K160171 · Aegis Surgical, Ltd. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Feb 2016
Decision
30d
Days
Class 2
Risk

K160171 is an FDA 510(k) clearance for the Illuminated Mediastinal Access Port. Classified as Mediastinoscope, Surgical (product code EWY), Class II - Special Controls.

Submitted by Aegis Surgical, Ltd. (Durham, US). The FDA issued a Cleared decision on February 26, 2016 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4720 - 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 Aegis Surgical, Ltd. devices

Submission Details

510(k) Number K160171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date February 26, 2016
Days to Decision 30 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
59d faster than avg
Panel avg: 89d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EWY Mediastinoscope, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4720
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.