Cleared Traditional

K223469 - WallFlex Biliary RX Stent System

K223469 is the FDA 510(k) clearance for WallFlex Biliary RX Stent System by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K223469 · Boston Scientific Corporation · Gastroenterology & Urology device
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Jun 2023
Decision
210d
Days
Class 2
Risk

K223469 is an FDA 510(k) clearance for the WallFlex™ Biliary RX Stent System. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on June 15, 2023 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K223469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 17, 2022
Decision Date June 15, 2023
Days to Decision 210 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
80d slower than avg
Panel avg: 130d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 299
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K223469.
EndoGI S-Path Biliary Stent System
K232596 · Endogi Medical, Ltd. · Sep 2023
EGIS Biliary Single Bare Stent
K223354 · S&G Biotech, Inc. · Sep 2023
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
K230127 · Micro-Tech (Nanjing) Co., Ltd. · Sep 2023
Niti-S Biliary Speed D Stent
K223626 · Taewoong Medical Co., Ltd. · May 2023
MultiStage Balloon Dilatation Catheter
K222663 · Dongguan TT Medical, Inc. · Mar 2023
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
K223592 · Boston Scientific Corporation · Dec 2022