Cleared Traditional

K233939 - Ultraflex Esophageal NG Stent System (FDA 510(k) Clearance)

Also includes:
WallFlex Esophageal Stent System

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233939 · Boston Scientific · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
137d
Days
Class 2
Risk

K233939 is an FDA 510(k) clearance for the Ultraflex Esophageal NG Stent System. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Boston Scientific (Marborough, US). The FDA issued a Cleared decision on April 29, 2024 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - 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 devices

Submission Details

510(k) Number K233939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2023
Decision Date April 29, 2024
Days to Decision 137 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
7d slower than avg
Panel avg: 130d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ESW Prosthesis, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
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 - ESW Prosthesis, Esophageal

All 58
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K233939.
Niti-S Esophageal Stent
K243619 · Taewoong Medical Co., Ltd. · Oct 2025
HANAROSTENT Esophagus Upper (CCC)
K253327 · M.I. Tech Co., Ltd. · Oct 2025
Resilience Fully Covered Esophageal Stent System
K251265 · Merit Medical Systems, Inc. · Jul 2025
Agile Esophageal Stent System
K233837 · Boston Scientific Corporation · Apr 2024
Esophageal TTS Stent
K240522 · Taewoong Medical · Mar 2024
Hilzo Esophageal Stents
K223266 · Thoracent, Inc. · Jan 2024