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510(k) K251291

Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers by Boston Scientific — Product Code FGE

K251291 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers". The FDA issued a decision of Substantially Equivalent on July 3, 2025. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Boston Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
April 25, 2025
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 Boston Scientific

  • K260816 — OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging C (April 8, 2026)
  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K250468 — iSLEEVE Introducer Set (March 20, 2025)
  • K242950 — WallFlex Biliary PLUS RX Stent System (December 6, 2024)
  • K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (October 18, 2024)
  • K242507 — OBSIDIO™ Conformable Embolic (October 3, 2024)
  • K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX (August 30, 2024)
  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
  • K234002 — ICEfx Cryoablation System (FPRCH8000-02) (March 13, 2024)
  • K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Elec (November 28, 2023)

Other clearances for product code FGE

  • K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-08 (June 24, 2026)
  • K253832 — Dilation Balloon Catheter (April 24, 2026)
  • K251658 — Endoflux™ Biliary & Pancreatic Stent Sets (April 16, 2026)
  • K253987 — BARE Wireguided Balloon Dilation Catheter (1235) (March 13, 2026)
  • K253132 — Single use stone retrieval balloons (March 6, 2026)
  • K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (December 29, 2025)
  • 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)

FDA data resources