Cleared Traditional

K243619 - Niti-S Esophageal Stent (FDA 510(k) Clearance)

Also includes:
Esophageal TTS Stent

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

K243619 · Taewoong Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
342d
Days
Class 2
Risk

K243619 is an FDA 510(k) clearance for the Niti-S Esophageal Stent. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Taewoong Medical Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on October 30, 2025 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Taewoong Medical Co., Ltd. devices

Submission Details

510(k) Number K243619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2024
Decision Date October 30, 2025
Days to Decision 342 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
212d slower than avg
Panel avg: 130d · This submission: 342d
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 Consultant

Biologics Consulting Group
Matthew Krueger

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ESW Prosthesis, Esophageal

All 58
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K243619.
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
Esophageal TTS Stent
K240522 · Taewoong Medical · Mar 2024
Hilzo Esophageal Stents
K223266 · Thoracent, Inc. · Jan 2024