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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mediastinoscope, Surgical
510(k) Number K160171
Device Name Illuminated Mediastinal Access Port
Applicant
Aegis Surgical, Ltd.
4020 Stirrup Creek Dr.
Suite 115
Durham,  NC  27703
Applicant Contact William Starling
Correspondent
Aegis Surgical, Ltd.
4020 Stirrup Creek Dr.
Suite 115
Durham,  NC  27703
Correspondent Contact Robert Hefter
Regulation Number874.4720
Classification Product Code
EWY  
Date Received01/27/2016
Decision Date 02/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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