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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 K262913
Device Name Protégé™ EverFlex™ Self-expanding Peripheral Stent System
Applicant
Medtronic, Inc.
2300 Berkshire Ln. N.
Plymouth,  MN  55441
Applicant Contact Kim Wallner
Correspondent
Medtronic, Inc.
2300 Berkshire Ln. N.
Plymouth,  MN  55441
Correspondent Contact Kim Wallner
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/19/2026
Decision Date 09/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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