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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope
510(k) Number K162332
Device Name Nexcore GI Insufflator
Applicant
Nexcore Technology, LLC
P.O. Box 903
Winchester,  MA  01890
Applicant Contact Julie Broderick
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact Olaf Teichert
Regulation Number876.1500
Classification Product Code
FCX  
Date Received08/19/2016
Decision Date 09/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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