Cleared Traditional

K140630 - WALLFLEX BILIARY RX STENT SYSTEM

K140630 is the FDA 510(k) clearance for WALLFLEX BILIARY RX STENT SYSTEM by Boston Scientific. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K140630 · Boston Scientific · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
73d
Days
Class 2
Risk

K140630 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 (Marlboro, US). The FDA issued a Cleared decision on May 23, 2014 after a review of 73 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

Submission Details

510(k) Number K140630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 11, 2014
Decision Date May 23, 2014
Days to Decision 73 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: 130d · This submission: 73d
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 253
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K140630.
EXPEL APD DRAINAGE CATHETER SYSTEM
K141335 · Boston Scientific Corp · Oct 2014
MUSTANG BALLOON DIALATION CATHETER
K141597 · Boston Scientific Corporation · Aug 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
K133110 · Boston Scientific Corporation · Jul 2014
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
K133700 · Boston Scientific Corporation · May 2014
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
K130981 · Cordis Corp. · Mar 2014
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
K131201 · Cook, Inc. · Oct 2013