E·Luminexx® Biliary Stent
E·Luminexx® Biliary Stent 12 mm x 100 mm (135 cm delivery catheter)
6manufacturers in China registered for this device type
64catalogue numbers in this listing
2510(k) clearances naming this product code
40recalls 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 | Bard Peripheral Vascular, Inc., United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| Record published | 2015-07-14 |
| Record revised | 2024-04-22 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Away from Sunlight; Special storage condition: Keep Dry |
| Distribution end date | 2023-04-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZBL14040 | Catheter Length, 135 Centimeter | In distribution |
| ZBM12030 | Inner Diameter, 12 Millimeter | In distribution |
| ZBM14100 | Stent Length, 100 Millimeter | In distribution |
| ZBM12080 | Stent Length, 80 Millimeter | In distribution |
| ZBL06060 | Stent Length, 60 Millimeter | In distribution |
| ZBM14020 | Stent Length, 20 Millimeter | In distribution |
| ZBM06080 | Inner Diameter, 6 Millimeter | In distribution |
| ZBM12060 | Stent Length, 60 Millimeter | In distribution |
| ZBM06100 | Catheter Length, 80 Centimeter | In distribution |
| ZBM12120 | Stent Length, 120 Millimeter | In distribution |
| ZBM12100 | Inner Diameter, 12 Millimeter | In distribution |
| ZBL14020 | Stent Length, 20 Millimeter | In distribution |
| ZBM14030 | Stent Length, 30 Millimeter | In distribution |
| ZBL07120 | Stent Length, 120 Millimeter | In distribution |
| ZBL12100 | Catheter Length, 135 Centimeter | In distribution |
| ZBL06020 | Catheter Length, 135 Centimeter | In distribution |
| ZBL14080 | Catheter Length, 135 Centimeter | In distribution |
| ZBL14060 | Catheter Length, 135 Centimeter | In distribution |
| ZBM14120 | Stent Length, 120 Millimeter | In distribution |
| ZBM06020 | Inner Diameter, 6 Millimeter | In distribution |
| ZBL14120 | Catheter Length, 135 Centimeter | In distribution |
| ZBL06040 | Inner Diameter, 6 Millimeter | In distribution |
| ZBM09120 | Stent Length, 120 Millimeter | In distribution |
| ZBL06030 | Inner Diameter, 6 Millimeter | In distribution |
| ZBL14030 | Catheter Length, 135 Centimeter | In distribution |
| ZBM06030 | Stent Length, 30 Millimeter | In distribution |
| ZBM12040 | Stent Length, 40 Millimeter | In distribution |
| ZBM14060 | Inner Diameter, 14 Millimeter | In distribution |
| ZBM06040 | Inner Diameter, 6 Millimeter | In distribution |
| ZBL06120 | Stent Length, 120 Millimeter | In distribution |
| ZBM14080 | Inner Diameter, 14 Millimeter | In distribution |
| ZBL12030 | Catheter Length, 135 Centimeter | In distribution |
| ZBL12120 | Catheter Length, 135 Centimeter | In distribution |
| ZBL10120 | Inner Diameter, 10 Millimeter | In distribution |
| ZBL12080 | Stent Length, 80 Millimeter | In distribution |
| ZBL12040 | Stent Length, 40 Millimeter | In distribution |
| ZBM07120 | Catheter Length, 80 Centimeter | In distribution |
| ZBL06100 | Inner Diameter, 6 Millimeter | In distribution |
| ZBM14040 | Catheter Length, 80 Centimeter | In distribution |
| ZBL06080 | Stent Length, 80 Millimeter | In distribution |
| ZBM12020 | Stent Length, 20 Millimeter | In distribution |
| ZBM10120 | Catheter Length, 80 Centimeter | In distribution |
| ZBL09120 | Stent Length, 120 Millimeter | In distribution |
| ZBL08120 | Stent Length, 120 Millimeter | In distribution |
| ZBM06060 | Catheter Length, 80 Centimeter | In distribution |
| ZBL12060 | Inner Diameter, 12 Millimeter | In distribution |
| ZBM06120 | Inner Diameter, 6 Millimeter | In distribution |
| ZBL12020 | Catheter Length, 135 Centimeter | In distribution |
| ZBL14100 | Stent Length, 100 Millimeter | In distribution |
| ZBM08120 | Stent Length, 120 Millimeter | In distribution |
| ZBL04020 | Catheter Length, 135 Centimeter | Withdrawn |
| ZBL05020 | Catheter Length, 135 Centimeter | Withdrawn |
| ZBL05040 | Catheter Length, 135 Centimeter | Withdrawn |
| ZBL04120 | Inner Diameter, 4 Millimeter | Withdrawn |
| ZBL04080 | Inner Diameter, 4 Millimeter | Withdrawn |
| ZBL05100 | Inner Diameter, 5 Millimeter | Withdrawn |
| ZBL04100 | Catheter Length, 135 Centimeter | Withdrawn |
| ZBL05120 | Stent Length, 120 Millimeter | Withdrawn |
| ZBL05030 | Inner Diameter, 5 Millimeter | Withdrawn |
| ZBL04060 | Catheter Length, 135 Centimeter | Withdrawn |
| ZBL05080 | Inner Diameter, 5 Millimeter | Withdrawn |
| ZBL04040 | Inner Diameter, 4 Millimeter | Withdrawn |
| ZBL04030 | Stent Length, 30 Millimeter | Withdrawn |
| ZBL05060 | Catheter Length, 135 Centimeter | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063532 | 2008-05-30 |
| K052114 | 2005-08-25 |
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 |
|---|---|---|---|---|---|
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-12-23 | Not classified | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated “Now Approved for Vascular Use”. | 94 units total for all product codes | 2012-04-02 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 42 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 156 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 403 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 37 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 129 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 50 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 121 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 205 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 596 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 180 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 209 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 45 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 281 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 19 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 207 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 167 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 30 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 88 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 62 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 172 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 259 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 84 units | 2012-04-06 |
| 2008-08-29 | Not classified | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | 150 units | 2012-04-06 |
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.