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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K110291
Device Name NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE
Applicant
Smart Medical Systems , Ltd.
10 Hayetsira St.
Raanana,  IL 43663
Applicant Contact ADVA YOSELZON
Correspondent
Smart Medical Systems , Ltd.
10 Hayetsira St.
Raanana,  IL 43663
Correspondent Contact ADVA YOSELZON
Regulation Number876.1500
Classification Product Code
ODC  
Date Received02/01/2011
Decision Date 06/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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