Complete SE Biliary
Stent SC5100L Complete SE Long US 3L G
6manufacturers in China registered for this device type
12catalogue numbers in this listing
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 | Medtronic, 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, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K062264 |
| Record published | 2015-06-08 |
| Record revised | 2022-04-08 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store at room temperature in a dark, dry place |
| Sizes | Length 20 to 150 mm |
| Distribution end date | 2019-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC560L | Stent Inner Diameter 5 MM | In distribution |
| SC580L | Stent Inner Diameter 5 MM | Withdrawn |
| SC440L | Length 40.0 mm | Withdrawn |
| SC5100L | Stent Inner Diameter 5 MM | Withdrawn |
| SC5120L | Length 120.0 mm | Withdrawn |
| SC520L | Stent Inner Diameter 5 MM | Withdrawn |
| SC540L | Length 40.0 mm | Withdrawn |
| SC430L | Length 30.0 mm | Withdrawn |
| SC420L | Length 20.0 mm | Withdrawn |
| SC7150L | Length 150.0 mm | Withdrawn |
| SC6150L | Stent Inner Diameter 6 MM | Withdrawn |
| SC530L | Stent Inner Diameter 5 MM | Withdrawn |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 |
|---|---|---|---|---|---|---|---|
| Medtronic Vascular | 510(k) number | 2009-07-17 | Not classified | Labeling mix-ups | Mislabeling– A lot of 5 mm x 120 mm stents were labeled as 6 mm x 80 mm stents and vice versa. | 20 units | 2010-06-21 |
| Medtronic Vascular | 510(k) number | 2009-07-17 | Not classified | Labeling mix-ups | Mislabeling– A lot of 5 mm x 12 mm stents were labeled as 6 mm x 80 mm stents and vice versa. | 20 units | 2010-06-21 |
| Medtronic CardioVascular | 510(k) number | 2008-11-24 | Not classified | Process control | Mislabeled: Product may contain wrong instructions for use– may contain International IFU instead of the correct US (for Biliary indication use only) IFU. | 23 units | 2009-03-27 |
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.