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510(k) K242845

EGIS Biliary Double Bare Stent (BDB080405) by S&G Biotech, Inc. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
June 25, 2025
Date Received
September 20, 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

Other clearances by S&G Biotech, Inc.

  • K223354 — EGIS Biliary Single Bare Stent (September 21, 2023)

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