Gore Viabil Biliary Endoprosthesis
VIABIL SHORT WIRE BILIARY ENDO 10mmX10cmX200cm 8.5Fr
6manufacturers in China registered for this device type
42catalogue numbers in this listing
3510(k) clearances naming this product code
4recalls 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 | W. L. Gore & Associates, 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 |
| 510(k) | K041423 |
| Record published | 2016-03-07 |
| Record revised | 2023-08-29 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Catheter gauge 8.5 to 10 Fr; length 4 to 10 cm; lumen/inner diameter 8 to 10 mm; outer diameter 8 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VN1004040 | Catheter Gauge 10 Fr | In distribution |
| VN0806040 | Catheter Gauge 10 Fr | In distribution |
| VSWVH0806 | Catheter Working Length: 200 CM | In distribution |
| VSWVN1008 | Catheter Working Length: 200 CM | In distribution |
| VSWVN0806 | Length 6 cm | In distribution |
| VH0810040 | Catheter Gauge 10 Fr | In distribution |
| VN0804040 | Catheter Gauge 10 Fr | In distribution |
| VN1008040 | Catheter Gauge 10 Fr | In distribution |
| VH0806040 | Catheter Gauge 10 Fr | In distribution |
| VN0810040 | Catheter Gauge 10 Fr | In distribution |
| VN0808040 | Catheter Gauge 10 Fr | In distribution |
| VH1008200 | Lumen/Inner Diameter 10 mm | In distribution |
| VH1010200 | Lumen/Inner Diameter 10 mm | In distribution |
| VSWVN0810 | Length 10 cm | In distribution |
| VN0806200 | Lumen/Inner Diameter 8 mm | In distribution |
| VH0806200 | Lumen/Inner Diameter 8 mm | In distribution |
| VSWVN0808 | Catheter Working Length: 200 CM | In distribution |
| VH1010040 | Catheter Gauge 10 Fr | In distribution |
| VN1010200 | Lumen/Inner Diameter 10 mm | In distribution |
| VN1006200 | Lumen/Inner Diameter 10 mm | In distribution |
| VH0810200 | Lumen/Inner Diameter 8 mm | In distribution |
| VSWVH0808 | Length 8 cm | In distribution |
| VN0808200 | Lumen/Inner Diameter 8 mm | In distribution |
| VSWVN0804 | Catheter Working Length: 200 CM | In distribution |
| VSWVH1010 | Length 10 cm | In distribution |
| VSWVN1004 | Catheter Working Length: 200 CM | In distribution |
| VH1008040 | Catheter Gauge 10 Fr | In distribution |
| VN0810200 | Lumen/Inner Diameter 8 mm | In distribution |
| VSWVH1006 | Length 6 cm | In distribution |
| VH0808200 | Lumen/Inner Diameter 8 mm | In distribution |
| VN1006040 | Catheter Gauge 10 Fr | In distribution |
| VN0804200 | Lumen/Inner Diameter 8 mm | In distribution |
| VN1004200 | Lumen/Inner Diameter 10 mm | In distribution |
| VSWVN1010 | Length 10 cm | In distribution |
| VN1010040 | Catheter Gauge 10 Fr | In distribution |
| VN1008200 | Lumen/Inner Diameter 10 mm | In distribution |
| VSWVN1006 | Length 6 cm | In distribution |
| VH0808040 | Catheter Gauge 10 Fr | In distribution |
| VSWVH0810 | Catheter Working Length: 200 CM | In distribution |
| VH1006040 | Catheter Gauge 10 Fr | In distribution |
| VSWVH1008 | Catheter Working Length: 200 CM | In distribution |
| VH1006200 | Lumen/Inner Diameter 10 mm | In distribution |
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 |
|---|---|
| K170740 | 2017-05-08 |
| K041423 | 2004-07-21 |
| K014215 | 2002-12-19 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| W. L. Gore & Associates, Inc. | 510(k) number | 2026-05-22 | Class II | Process control | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). | 13 units | |
| W. L. Gore & Associates, Inc. | 510(k) number | 2026-05-22 | Class II | Process control | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). | 13 units | |
| W. L. Gore & Associates, Inc. | 510(k) number | 2024-01-19 | Class II | Packaging process control | Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cho | 24 | |
| W. L. Gore & Associates, Inc. | 510(k) number | 2021-04-05 | Class II | Process change control | The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length. | 61 devices | 2024-01-16 |
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.