Gastroenterology & Urology › TherapeuticStents, Drains And Dilators For The Biliary Ducts

Biliary Plastic Stent

TPU, Double pigtails,8.5Fr,12cm

Registry build 21.09.26
6manufacturers in China registered for this device type
90catalogue numbers in this listing
5510(k) clearances naming this product code

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 Biliary Plastic Stent
Listed by Micro-Tech (Nanjing) Co., Ltd., China
FDA product code FGE
Device type Stents, Drains And Dilators For The Biliary Ducts
Device class Class 2
Regulation 21 CFR 876.5010
Establishment Contract manufacturer, Contract steriliser, Manufacturer
510(k) K230127
Record published 2023-10-31
Record revised 2025-12-15 (version 4)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 10, case of 30
Sizes Stent diameter 2.3 to 3.8 mm; stent length 30 to 180 mm; shaft length 70 to 150 mm; stent length 2.83 µm

Catalogue Numbers

Catalogue numbers for Biliary Plastic Stent
Catalogue number Size Status
BPDS-44114-1115 Stent Diameter 3.8 mm In distribution
BPDS-43114-1115 Stent Diameter 3.8 mm In distribution
BPDS-41993-0812 Stent Diameter 2.9 mm In distribution
BPDS-41993-0815 Stent Diameter 2.9 mm In distribution
BPDS-41114-0812 Stent Diameter 2.83 mm In distribution
BPDS-44114-0807 Stent Diameter 2.9 mm In distribution
BPDS-41993-0703 Stent Diameter 2.35 mm In distribution
BPDS-41114-1107 Stent Diameter 3.8 mm In distribution
BPDS-44114-1012 Stent Diameter 3.3 mm In distribution
BPDS-43114-1018 Stent Diameter 3.3 mm In distribution
BPDS-44114-1107 Stent Diameter 3.8 mm In distribution
BPDS-41993-0710 Stent Diameter 2.35 mm In distribution
BPDS-41114-0712 Stent Diameter 2.3 mm In distribution
BPDS-44114-0818 Stent Diameter 2.9 mm In distribution
BPDS-43114-1012 Stent Diameter 3.3 mm In distribution
BPDS-41114-0707 Stent Diameter 2.3 mm In distribution
BPDS-41993-1010 Stent Diameter 3.3 mm In distribution
BPDS-41114-1018 Stent Diameter 3.3 mm In distribution
BPDS-41114-0718 Stent Diameter 2.3 mm In distribution
BPDS-41114-1118 Stent Diameter 3.8 mm In distribution
BPDS-44114-1015 Stent Diameter 3.3 mm In distribution
BPDS-41114-0807 Stent Diameter 2.83 mm In distribution
BPDS-43114-1015 Stent Diameter 3.3 mm In distribution
BPDS-41114-0709 Stent Diameter 2.3 mm In distribution
BPDS-41993-0712 Stent Diameter 2.35 mm In distribution
BPDS-44114-1009 Stent Diameter 3.3 mm In distribution
BPDS-41114-0815 Stent Length 2.83 µm In distribution
BPDS-43114-0809 Stent Diameter 2.9 mm In distribution
BPDS-41993-0707 Stent Diameter 2.35 mm In distribution
BPDS-41993-0715 Stent Diameter 2.35 mm In distribution
BPDS-44114-0705 Stent Diameter 2.35 mm In distribution
BPDS-41993-0803 Stent Diameter 2.9 mm In distribution
BPDS-41114-1115 Stent Diameter 3.8 mm In distribution
BPDS-41993-0805 Stent Diameter 2.9 mm In distribution
BPDS-43114-0709 Stent Diameter 2.35 mm In distribution
BPDS-44114-0805 Stent Diameter 2.9 mm In distribution
BPDS-44114-0709 Stent Diameter 2.35 mm In distribution
BPDS-41114-1009 Stent Diameter 3.3 mm In distribution
BPDS-41993-1003 Stent Diameter 3.3 mm In distribution
BPDS-43114-0718 Stent Diameter 2.35 mm In distribution
BPDS-43114-1005 Stent Diameter 3.3 mm In distribution
BPDS-41993-0810 Stent Diameter 2.9 mm In distribution
BPDS-44114-1018 Stent Diameter 3.3 mm In distribution
BPDS-41114-1012 Stent Diameter 3.3 mm In distribution
BPDS-43114-0807 Stent Diameter 2.9 mm In distribution
BPDS-41114-1105 Stent Diameter 3.8 mm In distribution
BPDS-43114-0705 Stent Diameter 2.35 mm In distribution
BPDS-41993-1007 Stent Diameter 3.3 mm In distribution
BPDS-41114-0818 Stent Diameter 2.83 mm In distribution
BPDS-44114-1109 Stent Diameter 3.8 mm In distribution
BPDS-43114-1112 Stent Diameter 3.8 mm In distribution
BPDS-41114-0715 Stent Diameter 2.3 mm In distribution
BPDS-43114-1118 Stent Diameter 3.8 mm In distribution
BPDS-43114-1009 Stent Diameter 3.3 mm In distribution
BPDS-43114-0707 Stent Diameter 2.35 mm In distribution
BPDS-44114-0718 Stent Diameter 2.35 mm In distribution
BPDS-44114-1007 Stent Diameter 3.3 mm In distribution
BPDS-44114-0715 Stent Diameter 2.35 mm In distribution
BPDS-43114-0712 Stent Diameter 2.35 mm In distribution
BPDS-43114-0812 Stent Diameter 2.9 mm In distribution
BPDS-41993-0807 Stent Diameter 2.9 mm In distribution
BPDS-44114-0712 Stent Diameter 2.35 mm In distribution
BPDS-43114-0805 Stent Diameter 2.9 mm In distribution
BPDS-41114-0705 Stent Length 50 mm In distribution
BPDS-41114-1007 Stent Diameter 3.3 mm In distribution
BPDS-44114-1112 Stent Diameter 3.8 mm In distribution
BPDS-43114-1105 Stent Diameter 3.8 mm In distribution
BPDS-41114-1005 Stent Diameter 3.3 mm In distribution
BPDS-41114-0805 Stent Diameter 2.83 mm In distribution
BPDS-44114-1118 Stent Diameter 3.8 mm In distribution
BPDS-41993-1005 Stent Diameter 3.3 mm In distribution
BPDS-44114-0809 Stent Diameter 2.9 mm In distribution
BPDS-43114-1007 Stent Diameter 3.3 mm In distribution
BPDS-44114-0707 Stent Diameter 2.35 mm In distribution
BPDS-43114-0818 Stent Diameter 2.9 mm In distribution
BPDS-41993-1015 Stent Diameter 3.3 mm In distribution
BPDS-41114-1112 Stent Diameter 3.8 mm In distribution
BPDS-41114-1109 Stent Diameter 3.8 mm In distribution
BPDS-41114-0809 Stent Diameter 2.83 mm In distribution
BPDS-44114-1105 Stent Diameter 3.8 mm In distribution
BPDS-41993-0705 Stent Diameter 2.35 mm In distribution
BPDS-44114-1005 Stent Diameter 3.3 mm In distribution
BPDS-43114-1107 Stent Diameter 3.8 mm In distribution
BPDS-41114-1015 Stent Diameter 3.3 mm In distribution
BPDS-41993-1012 Stent Diameter 3.3 mm In distribution
BPDS-43114-0715 Stent Diameter 2.35 mm In distribution
BPDS-43114-1109 Stent Diameter 3.8 mm In distribution
BPDS-44114-0815 Stent Diameter 2.9 mm In distribution
BPDS-44114-0812 Stent Diameter 2.9 mm In distribution
BPDS-43114-0815 Stent Diameter 2.9 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
M-Drain Mermaid Medical A/S 86
Advanix™ Biliary Boston Scientific Corporation 84
Visi-Pro™ Covidien LP 81

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K230127 2023-09-06
K211021 2022-05-06
K180418 2018-10-15
K162226 2017-01-25
K151671 2015-10-16

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