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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K140441
Device Name BI-FLEX URETERAL ACCESS SHEATH
Applicant
Promepla Sam
Le Copori-9 Ave.
Prince Albert Ii
Monaco,  MC MC 9800
Applicant Contact MOHAMED REKIK
Correspondent
Promepla Sam
Le Copori-9 Ave.
Prince Albert Ii
Monaco,  MC MC 9800
Correspondent Contact MOHAMED REKIK
Regulation Number876.5130
Classification Product Code
KNY  
Date Received02/21/2014
Decision Date 06/17/2014
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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