Hanarostent® Biliary (NNN)
Hanarostent Biliary NNN is an uncovered, self-expanding Nitinol stent for palliation of malignant bile-duct strictures. The tubular wire mesh expands at body temperature to support the…
Hanarostent Biliary NNN is an uncovered, self-expanding Nitinol stent for palliation of malignant bile-duct strictures. The tubular wire mesh expands at body temperature to support the narrowed duct.
The stent is supplied with an introducer for percutaneous or endoscopic placement. Pulling back the outer sheath releases the stent from the delivery system.
Listed Item
Un-covered self-expanding nitinol biliary stent
Stent and Delivery Options
The range includes 8 and 10 mm stent diameters and lengths from 40 to 120 mm. Gold markers identify the stent on imaging. The single-use system has different introducer lengths for its percutaneous and endoscopic approaches.
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 | M.I.Tech Co Ltd, South Korea |
|---|---|
| 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 |
| 510(k) | K111149 |
| Record published | 2017-07-03 |
| Record revised | 2026-01-02 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 35 °C |
| Sizes | Length 40 to 120 mm; lumen/inner diameter 8 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SHS-10-100-060 | 600mm | In distribution |
| SHS-08-090-180 | 1800mm | In distribution |
| SHS-08-070-180 | 1800mm | In distribution |
| SHS-10-070-060 | 600mm | In distribution |
| SHS-08-080-060 | 600mm | In distribution |
| SHS-08-080-180 | 1800mm | In distribution |
| SHS-10-090-180 | 1800mm | In distribution |
| SHS-10-060-060 | 600mm | In distribution |
| SHS-10-050-180 | 1800mm | In distribution |
| SHS-10-040-180 | 1800mm | In distribution |
| SHS-08-120-180 | 1800mm | In distribution |
| SHS-08-060-060 | 600mm | In distribution |
| SHS-08-100-060 | 600mm | In distribution |
| SHS-10-090-060 | 600mm | In distribution |
| SHS-10-100-180 | 1800mm | In distribution |
| SHS-08-040-060 | 600MM | In distribution |
| SHS-10-040-060 | 600mm | In distribution |
| SHS-08-060-180 | 1800mm | In distribution |
| SHS-08-050-180 | 1800mm | In distribution |
| SHS-10-120-060 | 600mm | In distribution |
| SHS-10-070-180 | 1800mm | In distribution |
| SHS-10-060-180 | 1800mm | In distribution |
| SHS-08-120-060 | 600mm | In distribution |
| SHS-10-080-180 | 1800mm | In distribution |
| SHS-10-120-180 | 1800mm | In distribution |
| SHS-08-070-060 | 600mm | In distribution |
| SHS-08-100-180 | 1800mm | In distribution |
| SHS-10-080-060 | 600mm | In distribution |
| SHS-08-090-060 | 600mm | In distribution |
| SHS-08-050-060 | 600mm | In distribution |
| SHS-08-040-180 | 1800mm | In distribution |
| SHS-10-050-060 | 600mm | 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 |
|---|---|
| K202973 | 2021-05-11 |
| K183396 | 2019-02-11 |
| K111149 | 2011-12-30 |
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.