Hanarostent® Esophagus (NCN)
Hanarostent Esophagus NCN is a self-expanding Nitinol stent for supporting an esophageal lumen narrowed by malignant disease. Its wire mesh has a silicone covering and gold radiopaque…
Hanarostent Esophagus NCN is a self-expanding Nitinol stent for supporting an esophageal lumen narrowed by malignant disease. Its wire mesh has a silicone covering and gold radiopaque markers.
The stent is constrained within an over-the-wire delivery device. Retracting the outer sheath releases it, allowing outward radial force to support the esophageal passage.
Listed Item
Partially Covered metallic esophagus stent
Positioning and Delivery
Polymeric repositioning lassos at both ends assist positioning. Radiopaque markers identify the stent during placement, and the delivery system is removed after deployment. The system is intended for single use and includes specified guidewire-compatible delivery configurations.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | M.I.Tech Co Ltd, South Korea |
|---|---|
| FDA product code | ESW |
| Device type | Prosthesis, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3610 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K201160 |
| Record published | 2021-12-31 |
| 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 18 to 22 mm; stent length 80 to 150 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EPB22100-Z070 | Stent Diameter 22 mm | In distribution |
| EPB22150-Z070 | Stent Diameter 22 mm | In distribution |
| EPB20080-X070 | Stent Diameter 20 mm | In distribution |
| EPB20150-X070 | Stent Diameter 20 mm | In distribution |
| EPB20090-X070 | Stent Diameter 20 mm | In distribution |
| EPB20110-X070 | Stent Diameter 20 mm | In distribution |
| EPB22130-Z070 | Stent Diameter 22 mm | In distribution |
| EPB22120-Z070 | Stent Diameter 22 mm | In distribution |
| EPB22080-Z070 | Stent Diameter 22 mm | In distribution |
| EPB20130-X070 | Stent Diameter 20 mm | In distribution |
| EPB18100-X070 | Stent Diameter 18 mm | In distribution |
| EPB20100-X070 | Stent Diameter 20 mm | In distribution |
| EPB20140-X070 | Stent Diameter 20 mm | In distribution |
| EPB18150-X070 | Stent Diameter 18 mm | In distribution |
| EPB18120-X070 | Stent Diameter 18 mm | In distribution |
| EPB22110-Z070 | Stent Diameter 22 mm | In distribution |
| EPB18090-X070 | Stent Diameter 18 mm | In distribution |
| EPB18140-X070 | Stent Diameter 18 mm | In distribution |
| EPB18110-X070 | Stent Diameter 18 mm | In distribution |
| EPB18080-X070 | Stent Diameter 18 mm | In distribution |
| EPB22140-Z070 | Stent Diameter 22 mm | In distribution |
| EPB22090-Z070 | Stent Diameter 22 mm | In distribution |
| EPB20120-X070 | Stent Diameter 20 mm | In distribution |
| EPB18130-X070 | Stent Diameter 18 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hilzo Esophageal stents | BCM Co., Ltd. | 464 |
| Esophageal TTS Stent | Taewoongmedical.co., Ltd. | 144 |
| Hanarostent® Esophagus (CCC) | M.I.Tech Co Ltd | 44 |
| Hanarostent® Esophagus TTS(NCN) | M.I.Tech Co Ltd | 40 |
| Hanarostent® Esophagus TTS(CCC) | M.I.Tech Co Ltd | 40 |
| Niti-S Esophageal Stent | Taewoongmedical.co., Ltd. | 40 |
| Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 36 |
| Hanarostent® Esophagus Asymmetric (CCC) | M.I.Tech Co Ltd | 32 |
| Alimaxx-ES™ | Merit Medical Systems, Inc. | 27 |
| EndoMAXX® | Merit Medical Systems, Inc. | 24 |
| Agile™ Esophageal | Boston Scientific Corporation | 24 |
| Ultraflex™ Esophageal NG | Boston Scientific Corporation | 19 |
Showing 12 of 20. All products under Prosthesis, Esophageal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253327 | 2025-10-30 |
| K213251 | 2021-11-18 |
| K201160 | 2021-07-23 |
| K200860 | 2020-05-20 |
| K093537 | 2010-06-04 |
| K072094 | 2008-09-25 |
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.