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510(k) K243412

ARCHIMEDES Biodegradable Pancreatic Stent by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2025
Date Received
November 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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