Hanarostent® Benefit™ Biliary (NNN)
Hanarostent Benefit Biliary NNN is a self-expanding nitinol stent for palliative treatment of malignant narrowing in the biliary tree. Its tubular mesh applies outward radial force to…
Hanarostent Benefit Biliary NNN is a self-expanding nitinol stent for palliative treatment of malignant narrowing in the biliary tree. Its tubular mesh applies outward radial force to maintain the duct’s lumen.
The stent is preloaded in the distal portion of a polymer delivery system. Pulling back the outer sheath releases the stent so it can expand at the target site.
Listed Item
Un-covered self-expanding nitinol biliary stent
Stent Configuration
The Benefit design has straight ends and nine radiopaque markers. It offers 6 and 8 mm diameter configurations with different lengths for the treated region. The stent and delivery device are supplied sterile and are intended for single use.
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) | K202973 |
| Record published | 2021-08-31 |
| Record revised | 2026-01-02 (version 3) |
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 | Stent diameter 6 to 8 mm; stent length 40 to 120 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BNHS-08-040-180 | Stent Diameter 8 mm | In distribution |
| BNHS-06-120-060 | Stent Diameter 6 mm | In distribution |
| BNHS-08-100-180 | Stent Diameter 8 mm | In distribution |
| BNHS-06-120-180 | Stent Diameter 6 mm | In distribution |
| BNHS-06-040-180 | Stent Diameter 6 mm | In distribution |
| BNHS-08-070-180 | Stent Diameter 8 mm | In distribution |
| BNHS-08-100-060 | Stent Diameter 8 mm | In distribution |
| BNHS-08-060-180 | Stent Diameter 8 mm | In distribution |
| BNHS-06-090-060 | Stent Diameter 6 mm | In distribution |
| BNHS-06-100-180 | Stent Diameter 6 mm | In distribution |
| BNHS-08-050-180 | Stent Diameter 8 mm | In distribution |
| BNHS-08-110-180 | Stent Diameter 8 mm | In distribution |
| BNHS-08-090-180 | Stent Diameter 8 mm | In distribution |
| BNHS-08-090-060 | Stent Diameter 8 mm | In distribution |
| BNHS-08-040-060 | Stent Diameter 8 mm | In distribution |
| BNHS-08-060-060 | Stent Diameter 8 mm | In distribution |
| BNHS-08-110-060 | Stent Diameter 8 mm | In distribution |
| BNHS-08-080-060 | Stent Diameter 8 mm | In distribution |
| BNHS-06-070-060 | Stent Diameter 6 mm | In distribution |
| BNHS-06-080-060 | Stent Diameter 6 mm | In distribution |
| BNHS-06-100-060 | Stent Diameter 6 mm | In distribution |
| BNHS-08-120-180 | Stent Diameter 8 mm | In distribution |
| BNHS-06-050-060 | Stent Diameter 6 mm | In distribution |
| BNHS-08-120-060 | Stent Diameter 8 mm | In distribution |
| BNHS-06-050-180 | Stent Diameter 6 mm | In distribution |
| BNHS-08-070-060 | Stent Diameter 8 mm | In distribution |
| BNHS-06-070-180 | Stent Diameter 6 mm | In distribution |
| BNHS-08-080-180 | Stent Diameter 8 mm | In distribution |
| BNHS-06-060-060 | Stent Diameter 6 mm | In distribution |
| BNHS-06-110-180 | Stent Diameter 6 mm | In distribution |
| BNHS-06-110-060 | Stent Diameter 6 mm | In distribution |
| BNHS-08-050-060 | Stent Diameter 8 mm | In distribution |
| BNHS-06-080-180 | Stent Diameter 6 mm | In distribution |
| BNHS-06-040-060 | Stent Diameter 6 mm | In distribution |
| BNHS-06-090-180 | Stent Diameter 6 mm | In distribution |
| BNHS-06-060-180 | Stent Diameter 6 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 |
|---|---|
| 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.