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K Number

Validate with FDA (Live)

Device Name

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

Manufacturer

Taewoong Medical Co., Ltd.

Date Cleared

2025-12-29

(262 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Age Range

All

Reference & Predicate Devices

K240522,K250663,K221071,K073667

Predicate For

N/A

Why did this record match?

Reference Devices :

K240522, K250663

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Niti-S Biliary Stent:
The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.

Niti-S Biliary Slim M Stent:
The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the biliary tree.

Device Description

The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire. Two Nitinol wires are woven in a hook-type design. The stent design is identical to the predicate device cleared in K073667.

The Stent Delivery System is a disposable system for the delivery and deployment of the stent at the target position.

AI/ML Overview

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