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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K160356
Device Name Third Eye Panoramic Auxiliary Endoscopy System - Resposable
Applicant
AVANTIS MEDICAL SYSTEMS, INC.
2367 BERING DRIVE
San Jose,  CA  95131
Applicant Contact Louis Fries
Correspondent
AVANTIS MEDICAL SYSTEMS, INC.
2367 BERING DRIVE
San Jose,  CA  95131
Correspondent Contact Louis Fries
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
FDS  
Date Received02/08/2016
Decision Date 05/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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