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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 K243412
Device Name ARCHIMEDES Biodegradable Pancreatic Stent
Applicant
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
1800 Camden Rd., Suite 107
Charlotte,  NC  28203
Applicant Contact Eric Mangiardi
Correspondent
Hogan Lovells US LLP
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/01/2024
Decision Date 07/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT03767166
NCT04708288
NCT05307861
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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