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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K170833
Device Name EndoFLIP® System with FLIP Topography module
Applicant
Crospon, Ltd.
Galway Business Park
Dangan
Galway,  IE
Applicant Contact John O’Dea
Correspondent
Crospon Ltd., C/O Promedic, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34135
Correspondent Contact Paul Dryden
Regulation Number876.1725
Classification Product Code
FFX  
Date Received03/20/2017
Decision Date 04/17/2017
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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