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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophageal Dilator With Balloon And Electrode Sensors
510(k) Number K172128
Device Name EsoFLIP® ES-310 Balloon Catheter
Applicant
Crospon, Ltd.
Galway Business Park
Dangan
Galway,  IE
Applicant Contact John O’Dea
Correspondent
Crospon Ltd., C/O Promedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number876.5980
Classification Product Code
PIE  
Date Received07/14/2017
Decision Date 11/22/2017
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
Predetermined Change
Control Plan Authorized		 No
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