Cleared Traditional

K242950 - WallFlex Biliary PLUS RX Stent System

K242950 is an FDA 510(k) clearance for WallFlex Biliary PLUS RX Stent System, 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 74-day FDA review.

K242950 · Boston Scientific · Gastroenterology & Urology device
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Dec 2024
Decision
74d
Days
Class 2
Risk

K242950 is an FDA 510(k) clearance for the WallFlex Biliary PLUS RX Stent System. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific (Marlboro, US). The FDA issued a Cleared decision on December 6, 2024 after a review of 74 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 - K242950

510(k) Number K242950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received September 23, 2024
Decision Date December 06, 2024
Days to Decision 74 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
57d faster than avg
Panel avg: 131d · This submission: 74d
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 394
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K242950.
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
WallFlex Biliary RX Stent System
K240464 · Boston Scientific · Aug 2024
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS)
K233079 · Cook Ireland, Ltd. · Jun 2024
VedDilator ^TM (3-Stage Balloon Dilation Catheter)
K232245 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Feb 2024