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510(k) K240464

WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV by Boston Scientific — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
August 30, 2024
Date Received
February 16, 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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  • K232635 — IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H749396 (November 22, 2023)

Other clearances for product code FGE

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  • K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (December 22, 2025)
  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K251229 — EndoFix™Tissue Fixation System (August 20, 2025)
  • K243412 — ARCHIMEDES Biodegradable Pancreatic Stent (July 16, 2025)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
  • K241888 — Single-use Balloon Dilatation Catheter (December 20, 2024)