Cleared Special

K240522 - Esophageal TTS Stent (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240522 · Taewoong Medical · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
28d
Days
Class 2
Risk

K240522 is an FDA 510(k) clearance for the Esophageal TTS Stent. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Taewoong Medical (Gyeonggi-Do, KR). The FDA issued a Cleared decision on March 22, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Taewoong Medical devices

Submission Details

510(k) Number K240522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2024
Decision Date March 22, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K240522.
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
Ultraflex Esophageal NG Stent System
K233939 · Boston Scientific · Apr 2024
Agile Esophageal Stent System
K233837 · Boston Scientific Corporation · Apr 2024
Hilzo Esophageal Stents
K223266 · Thoracent, Inc. · Jan 2024