Cleared Traditional

ILLUMINATED MEDIASTINOSCOPE

K141622 · Aegis Surgical, Ltd. · Ear, Nose, Throat

Jan 2015

Decision

206d

Days

Class 2

Risk

About This 510(k) Submission

K141622 is an FDA 510(k) clearance for the ILLUMINATED MEDIASTINOSCOPE, a Mediastinoscope, Surgical (Class II — Special Controls, product code EWY), submitted by Aegis Surgical, Ltd. (Holly Springs, US). The FDA issued a Cleared decision on January 9, 2015, 206 days after receiving the submission on June 17, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4720.

Submission Details

510(k) Number	K141622 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2014
Decision Date	January 09, 2015
Days to Decision	206 days
Submission Type	Traditional
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).