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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K151801
Device Name Arc Endocuff Vision
Applicant
Boddingtons Plastics, Ltd.
Wheelbarrow Park Estate
Pattenden Ln., Marden
Tonbridge,  GB TN12 9QL
Applicant Contact PAUL BLACKMORE
Correspondent
Boddingtons Plastics, Ltd.
Wheelbarrow Park Estate
Pattenden Ln., Marden
Tonbridge,  GB TN12 9QL
Correspondent Contact PAUL BLACKMORE
Regulation Number876.1500
Classification Product Code
FED  
Date Received07/02/2015
Decision Date 08/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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