Cleared Traditional

Advanix? Pancreatic Stent and NaviFlex? Rapid Exchange (RX) Pancreatic Delivery System and Pushers

K251291 · Boston Scientific · Gastroenterology & Urology
Jul 2025
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K251291 is an FDA 510(k) clearance for the Advanix? Pancreatic Stent and NaviFlex? Rapid Exchange (RX) Pancreatic Delivery System and Pushers, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Boston Scientific (Malborough, US). The FDA issued a Cleared decision on July 3, 2025, 69 days after receiving the submission on April 25, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number K251291 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2025
Decision Date July 03, 2025
Days to Decision 69 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FGE — Stents, Drains And Dilators For The Biliary Ducts
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5010

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