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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K253987
Device Name BARE Wireguided Balloon Dilation Catheter (1235)
Applicant
GIE Medical
7601 Northland Dr. N, Suite 170
Brooklyn Park,  MN  55428
Applicant Contact Ian Schorn
Correspondent
RQM+
5000 Centregreen Way
Cary,  NC  27513
Correspondent Contact Gabriela Molnar
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
KNQ  
Date Received12/12/2025
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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