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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 K162205
Device Name Arc EndoCuff and Arc EndoCuff Vision
Applicant
BODDINGTONS PLASTICS LTD
UNIT 6 PATTENDEN LANE,
MARDEN
TONBRIDGE,  GB TN12 9QJ
Applicant Contact SARAH GIBSON
Correspondent
BODDINGTONS PLASTICS LTD
UNIT 6 PATTENDEN LANE,
MARDEN
TONBRIDGE,  GB TN12 9QJ
Correspondent Contact SARAH GIBSON
Regulation Number876.1500
Classification Product Code
FED  
Date Received08/05/2016
Decision Date 12/09/2016
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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