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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K180605
Device Name GastroFlush
Applicant
Bionix Development Corporation
5154 Enterprise Blvd.
Toledo,  OH  43612
Applicant Contact James Huttner
Correspondent
Bionix Development Corporation
5154 Enterprise Blvd.
Toledo,  OH  43612
Correspondent Contact James Huttner
Regulation Number876.5980
Classification Product Code
KNT  
Subsequent Product Code
PIF  
Date Received03/07/2018
Decision Date 10/24/2018
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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