Cleared Special

K160171 - Illuminated Mediastinal Access Port

K160171 is an FDA 510(k) clearance for Illuminated Mediastinal Access Port, manufactured by Aegis Surgical, Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EWY cleared through the Special 510(k) pathway after a 30-day FDA review.

K160171 · Aegis Surgical, Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K160171

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 90d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

EWY Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EWY Mediastinoscope, Surgical

All 10
Devices cleared under the same product code (EWY) and FDA review panel - the closest regulatory comparables to K160171.
HD Mediastinoscope
K213194 · KARL STORZ Endoscopy-America, Inc. · Jun 2022
HD Mediastinoscope
K202272 · KARL STORZ Endoscopy-America, Inc. · May 2021
Aegis Transit System
K170757 · Boston-Biomedical Associates · Jul 2017
ILLUMINATED MEDIASTINOSCOPE
K141622 · Aegis Surgical, Ltd. · Jan 2015
OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE
K971166 · Richard Wolf Medical Instruments Corp. · Aug 1997
KARL STORZ OPTICAL MEDIASTINOSCOPE
K954910 · KARL STORZ Endoscopy-America, Inc. · Nov 1995