Cleared Traditional

K251291 - Advanix Pancreatic Stent and NaviFlex R...

K251291 is an FDA 510(k) clearance for Advanix Pancreatic Stent and NaviFlex R..., manufactured by Boston Scientific. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 69-day FDA review.

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

K251291 is an FDA 510(k) clearance for the Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delive.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific (Marborough, US). The FDA issued a Cleared decision on July 3, 2025 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific devices

FDA 510(k) Submission Details - K251291

510(k) Number K251291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 130d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 313
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K251291.
Disposable Balloon Catheter (B5-2Q)
K250409 · Olympus Medical Systems Corporation · Oct 2025
EndoFix™Tissue Fixation System
K251229 · Softac Medical Technologies · Aug 2025
ARCHIMEDES Biodegradable Pancreatic Stent
K243412 · Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · Jul 2025
EGIS Biliary Double Bare Stent (BDB080405)
K242845 · S&G Biotech, Inc. · Jun 2025
Single-use Balloon Dilatation Catheter
K241888 · Leo Medical Co., Ltd. · Dec 2024
Tornus ES
K241801 · Asahi Intecc Co., Ltd. · Dec 2024