Single Use Biliary Stent V
106 catalogue numbers from PBD-V602R-1012, listed by Olympus Medical Systems Corp., Japan, under Stents, Drains And Dilators For The Biliary Ducts. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
106catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| 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
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2023-01-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2022-08-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PBD-V602R-1012 | Withdrawn | |
| PBD-201-0807 | Withdrawn | |
| PBD-202-0812 | Withdrawn | |
| PBD-200-0807 | Withdrawn | |
| PBD-V600R-1009 | Withdrawn | |
| PBD-200-0809 | Withdrawn | |
| PBD-200-0703 | Withdrawn | |
| PBD-V601R-0705 | Withdrawn | |
| PBD-V600R-0709 | Withdrawn | |
| PBD-200-0805 | Withdrawn | |
| PBD-V600R-0812 | Withdrawn | |
| PBD-200-1007 | Withdrawn | |
| PBD-203-0710 | Withdrawn | |
| PBD-202-0709 | Withdrawn | |
| PBD-V602R-0712 | Withdrawn | |
| PBD-V602R-0805 | Withdrawn | |
| PBD-V600R-0705 | Withdrawn | |
| PBD-V602R-1015 | Withdrawn | |
| PBD-V601R-1007 | Withdrawn | |
| PBD-202-1007 | Withdrawn | |
| PBD-V601R-0815 | Withdrawn | |
| PBD-202-0707 | Withdrawn | |
| PBD-V601R-0812 | Withdrawn | |
| PBD-V602R-0809 | Withdrawn | |
| PBD-203-0704 | Withdrawn | |
| PBD-201-0707 | Withdrawn | |
| PBD-200-0709 | Withdrawn | |
| PBD-V600R-1012 | Withdrawn | |
| PBD-V602R-0707 | Withdrawn | |
| PBD-V601R-1009 | Withdrawn | |
| PBD-V602R-0705 | Withdrawn | |
| PBD-V601R-0707 | Withdrawn | |
| PBD-202-0712 | Withdrawn | |
| PBD-V602R-1007 | Withdrawn | |
| PBD-V600R-0807 | Withdrawn | |
| PBD-V600R-1007 | Withdrawn | |
| PBD-V601R-0712 | Withdrawn | |
| PBD-200-1009 | Withdrawn | |
| PBD-201-1012 | Withdrawn | |
| PBD-V600R-1015 | Withdrawn | |
| PBD-203-0703 | Withdrawn | |
| PBD-201-1009 | Withdrawn | |
| PBD-200-1003 | Withdrawn | |
| PBD-V600R-1003 | Withdrawn | |
| PBD-V621R-1015 | Withdrawn | |
| PBD-201-1005 | Withdrawn | |
| PBD-V601R-0807 | Withdrawn | |
| PBD-202-0815 | Withdrawn | |
| PBD-202-0715 | Withdrawn | |
| PBD-V602R-0807 | Withdrawn | |
| PBD-201-0809 | Withdrawn | |
| PBD-201-0812 | Withdrawn | |
| PBD-V601R-0709 | Withdrawn | |
| PBD-201-0715 | Withdrawn | |
| PBD-V600R-0803 | Withdrawn | |
| PBD-V600R-0805 | Withdrawn | |
| PBD-202-0705 | Withdrawn | |
| PBD-V602R-1005 | Withdrawn | |
| PBD-200-1015 | Withdrawn | |
| PBD-200-1005 | Withdrawn | |
| PBD-V600R-0809 | Withdrawn | |
| PBD-V602R-0709 | Withdrawn | |
| PBD-202-1012 | Withdrawn | |
| PBD-V601R-0805 | Withdrawn | |
| PBD-V600R-0703 | Withdrawn | |
| PBD-V602R-0815 | Withdrawn | |
| PBD-201-0705 | Withdrawn | |
| PBD-200-1012 | Withdrawn | |
| PBD-201-0815 | Withdrawn | |
| PBD-200-0815 | Withdrawn | |
| PBD-V601R-0809 | Withdrawn | |
| PBD-202-0805 | Withdrawn | |
| PBD-202-0807 | Withdrawn | |
| PBD-V601R-1005 | Withdrawn | |
| PBD-200-0705 | Withdrawn | |
| PBD-V600R-0712 | Withdrawn | |
| PBD-V601R-0715 | Withdrawn | |
| PBD-200-0707 | Withdrawn | |
| PBD-V601R-1015 | Withdrawn | |
| PBD-200-0803 | Withdrawn | |
| PBD-V600R-0715 | Withdrawn | |
| PBD-202-1015 | Withdrawn | |
| PBD-201-1007 | Withdrawn | |
| PBD-202-1009 | Withdrawn | |
| PBD-201-0805 | Withdrawn | |
| PBD-200-0715 | Withdrawn | |
| PBD-203-0715 | Withdrawn | |
| PBD-V621R-1009 | Withdrawn | |
| PBD-V621R-1007 | Withdrawn | |
| PBD-201-0712 | Withdrawn | |
| PBD-V621R-1012 | Withdrawn | |
| PBD-201-0709 | Withdrawn | |
| PBD-201-1015 | Withdrawn | |
| PBD-V600R-1005 | Withdrawn | |
| PBD-202-0809 | Withdrawn | |
| PBD-V600R-0815 | Withdrawn | |
| PBD-203-0707 | Withdrawn | |
| PBD-V602R-1009 | Withdrawn | |
| PBD-V601R-1012 | Withdrawn | |
| PBD-200-0812 | Withdrawn | |
| PBD-200-0712 | Withdrawn | |
| PBD-202-1005 | Withdrawn | |
| PBD-V602R-0715 | Withdrawn | |
| PBD-V602R-0812 | Withdrawn | |
| PBD-V600R-0707 | Withdrawn | |
| PBD-V621R-1005 | Withdrawn |
Same 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 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 |
| Visi-Pro™ | Covidien LP | 81 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250409 | 2025-10-21 |
| K143303 | 2015-02-27 |
| K103478 | 2011-02-24 |
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.