Cleared Traditional

K223067 - Niti-S Duodenal Stent

Also marketed or referenced as:
Niti-S Colonic Comfort Stent

K223067 is an FDA 510(k) clearance for Niti-S Duodenal Stent, manufactured by Taewoong Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MUM cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K223067 · Taewoong Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
264d
Days
Class 2
Risk

K223067 is an FDA 510(k) clearance for the Niti-S Duodenal Stent. Classified as Stent, Metallic, Expandable, Duodenal (product code MUM), Class II - Special Controls.

Submitted by Taewoong Medical Co., Ltd. (Gimpo-Si, KR). The FDA issued a Cleared decision on June 14, 2023 after a review of 264 days - an extended review cycle.

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 Taewoong Medical Co., Ltd. devices

FDA 510(k) Submission Details - K223067

510(k) Number K223067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2022
Decision Date June 14, 2023
Days to Decision 264 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
134d slower than avg
Panel avg: 130d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUM Device Classification - Class 2, Special Controls

Product Code MUM Stent, Metallic, Expandable, Duodenal
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

MED Institute
Daniel J Dillon

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 - MUM Stent, Metallic, Expandable, Duodenal

Devices cleared under the same product code (MUM) and FDA review panel - the closest regulatory comparables to K223067.
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
K250663 · Taewoong Medical Co., Ltd. · Mar 2025
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
K163468 · Cook Ireland, Ltd. · May 2017
EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
K101530 · Cook Ireland, Ltd. · Mar 2011
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
K062750 · Boston Scientific Corp · Dec 2006
WALLSTENT ENTERAL ENDOPROSTHESIS
K980113 · Boston Scientific Scimed, Inc. · Apr 1998