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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 K183072
Device Name EndoFLIP System
Applicant
Crospon, Ltd.
Galway Business Park
Dangan
Galway,  IE
Applicant Contact John O'Dea
Correspondent
Medtronic
2 Hacarmet St. New Industrial Park Pob 258
Yoqneam,  IL 20962
Correspondent Contact Avishag Metzer
Regulation Number876.1725
Classification Product Code
FFX  
Date Received11/05/2018
Decision Date 02/15/2019
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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