Cleared Special

Illuminated Mediastinal Access Port

K160171 · Aegis Surgical, Ltd. · Ear, Nose, Throat

Feb 2016

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K160171 is an FDA 510(k) clearance for the Illuminated Mediastinal Access Port, a Mediastinoscope, Surgical (Class II — Special Controls, product code EWY), submitted by Aegis Surgical, Ltd. (Durham, US). The FDA issued a Cleared decision on February 26, 2016, 30 days after receiving the submission on January 27, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4720.

Submission Details

510(k) Number	K160171 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	EWY — Mediastinoscope, Surgical
Device Class	Class II — 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).