Niti-S Biliary Stent

The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree. The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable,…

Registry build 21.09.26

The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree. The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the biliary system. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the biliary system to establish and maintain patency. The stent is available in two diameters (8, 10mm), and eight lengths (40, 50, 60, 70, 80, 90, 100, 120mm). The stent has 10 radiopaque markers. There are two different types of introducers; percutaneous or endoscopic. They consists of an Inner Catheter, Outer Sheath, Hub, Y-connector, Tip and Pusher. All of the components of the introducers are supplied sterile in a disposable package. The Percutaneous type introducer is used when the site is accessed percutaneously and requires a guidewire (not included) to be advanced across the targeted stricture under fluoroscopy. The Endoscopic type introducer is for use in endoscopic procedures where the stent and introducer are inserted through the channel of an endoscope. The usable lengths of Percutaneous type introducer is 50cm and Endoscopic type introducer 180cm. Other information: The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.035 inch (0.89mm). Do not use if package is damaged. Do not reuse or resterilize.

6manufacturers in China registered for this device type
32catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).

Chinese manufacturers registered for FDA product code FGE
Manufacturer City Province Registered as Device types
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Jiangsu Vedkang Medical Science and Technology Co., Ltd. Changzhou Jiangsu Manufacturer 20
Hangzhou AGS MedTech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 19
Dongguan TT Medical, Inc. Dongguan Guangdong Manufacturer 4
LEO Medical Co., Ltd. Changzhou Jiangsu Manufacturer 4

Record

Regulatory record for Niti-S Biliary Stent
Listed by Taewoongmedical.co., Ltd.
FDA product code FGE
Device type Stents, Drains And Dilators For The Biliary Ducts
Device class Class 2
Regulation 21 CFR 876.5010
510(k) K073667
Record published 2015-09-10
Record revised 2026-04-07 (version 6)

Specifications

Specifications
MRI safety MR Conditional
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries expiry date, manufacturing date, serial number
Sizes Length 40 to 120 mm; outer diameter 8 to 10 mm; catheter gauge 8 Fr

Catalogue Numbers

Catalogue numbers for Niti-S Biliary Stent
Catalogue number Size Status
TD0806 Length 60 mm In distribution
BD1010 Length 100 mm In distribution
TD0809 Length 90 mm In distribution
BD0804 Length 40 mm In distribution
TD0808 Length 80 mm In distribution
TD1004 Length 40 mm In distribution
BD1012 Length 120 mm In distribution
TD0804 Length 40 mm In distribution
TD0805 Length 50 mm In distribution
BD0809 Length 90 mm In distribution
BD1005 Length 50 mm In distribution
TD0810 Length 100 mm In distribution
TD1005 Length 50 mm In distribution
BD0806 Length 60 mm In distribution
BD0808 Length 80 mm In distribution
TD1010 Length 100 mm In distribution
BD1008 Length 80 mm In distribution
BD1006 Length 60 mm In distribution
BD1007 Length 70 mm In distribution
TD1006 Length 60 mm In distribution
BD0807 Length 70 mm In distribution
TD1007 Length 70 mm In distribution
TD1008 Length 80 mm In distribution
BD0805 Length 50 mm In distribution
BD1009 Length 90 mm In distribution
TD1012 Length 120 mm In distribution
BD0810 Length 100 mm In distribution
BD0812 Length 120 mm In distribution
TD1009 Length 90 mm In distribution
BD1004 Length 40 mm In distribution
TD0812 Length 120 mm In distribution
TD0807 Length 70 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Zimmon Cook Ireland Ltd 213
Single Use Biliary Drainage Stent V Olympus Medical Systems Corp. 181
Mustang™ Boston Scientific Corporation 167
Geenen Cook Ireland Ltd 158
Cotton-Leung Cook Ireland Ltd 144
Advanix™ Pancreatic Stent Boston Scientific Corporation 135
Single Use Biliary Stent V Olympus Medical Systems Corp. 106
Single-use Balloon Dilatation Catheter LEO Medical Co., Ltd. 102
Biliary Plastic Stent Set Micro-Tech (Nanjing) Co., Ltd. 90
Biliary Plastic Stent Micro-Tech (Nanjing) Co., Ltd. 90
M-Drain Mermaid Medical A/S 86
Advanix™ Biliary Boston Scientific Corporation 84

Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer