Flexxus® Endoscopic Biliary Stent
Flexxus® Endoscopic Biliary Stent, 10 mm x 100 mm (190cm deployment system)
6manufacturers in China registered for this device type
8catalogue numbers in this listing
7recalls on this 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 | Angiomed Gmbh & Co. Medizintechnik KG, Germany |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K031186 |
| Record published | 2015-10-02 |
| Record revised | 2024-08-12 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2023-04-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LXB10060 | Deployment System, 190 Centimeters | Withdrawn |
| LXB08060 | Diameter, 8 Millimeter | Withdrawn |
| LXB10080 | Deployment System, 190 Centimeters | Withdrawn |
| LXB08100 | Stent Length, 100 Millimeters | Withdrawn |
| LXB10040 | Diameter, 10 Millimeter | Withdrawn |
| LXB08080 | Deployment System, 190 Centimeters | Withdrawn |
| LXB10100 | Deployment System, 190 Centimeters | Withdrawn |
| LXB08040 | Stent Length, 40 Millimeters | Withdrawn |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 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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-03-14 | Not classified | Other | Blue safety clip incorrectly placed on the stent may prevent deployment | 11 UNITS | 2007-05-15 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-03-14 | Not classified | Other | Blue safety clip incorrectly placed on the stent may prevent deployment | 1 UNIT | 2007-05-15 |
| Angiomed Gmbh & Co. Medizintechnik KG | 510(k) number | 2005-07-28 | Not classified | Other | Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation. | 204 | 2006-05-02 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-07-28 | Not classified | Other | Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation. | 204 units | 2006-05-02 |
| 2005-07-28 | Not classified | Other | Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation. | 204 units | 2006-05-02 |
| 2005-07-28 | Not classified | Other | Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation. | 204 units | 2006-05-02 |
| 2005-07-28 | Not classified | Other | Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation. | 204 units | 2006-05-02 |
| 2005-07-28 | Not classified | Other | Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation. | 204 units | 2006-05-02 |
| 2005-07-28 | Not classified | Other | Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation. | 204 units | 2006-05-02 |
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.