Hanarostent® Esophagus Upper (CCC)
Hanarostent Esophagus Upper (CCC) is a fully covered self-expanding metal stent for malignant esophageal strictures and associated fistulas. It is intended to maintain the esophageal lumen…
Hanarostent Esophagus Upper (CCC) is a fully covered self-expanding metal stent for malignant esophageal strictures and associated fistulas. It is intended to maintain the esophageal lumen when intrinsic or extrinsic tumors cause narrowing. Its nitinol wire structure carries a silicone covering.
Gold-wire markers provide radiopacity, and polymer repositioning lassos are fitted at both ends. The stent is preloaded in an over-the-wire polymer delivery device. Withdrawing the outer sheath releases the stent to expand in the body.
Delivery Configuration
The system is intended for single use. The Upper version has its own proximal-head design and dimensions, with the described delivery method retained from the earlier CCC family. The repositioning lassos and covering are parts of the stent rather than separate implanted accessories.
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) | K253327 |
| Record published | 2025-12-23 |
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 20 mm; stent length 80 to 150 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ECP20100-X070 | 700MM | In distribution |
| ECP20140-X070 | 700MM | In distribution |
| ECP20110-X070 | 700MM | In distribution |
| ECP20090-X070 | 700MM | In distribution |
| ECP18110-X070 | 700MM | In distribution |
| ECP20080-X070 | 700MM | In distribution |
| ECP18140-X070 | 700MM | In distribution |
| ECP18150-X070 | 700MM | In distribution |
| ECP18130-X070 | 700MM | In distribution |
| ECP20150-X070 | 700MM | In distribution |
| ECP18100-X070 | 700MM | In distribution |
| ECP18090-X070 | 700MM | In distribution |
| ECP20120-X070 | 700MM | In distribution |
| ECP18080-X070 | 700MM | In distribution |
| ECP20130-X070 | 700MM | In distribution |
| ECP18120-X070 | 700MM | 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 |
| Hanarostent® Esophagus (NCN) | M.I.Tech Co Ltd | 24 |
| EndoMAXX® | Merit Medical Systems, Inc. | 24 |
| Agile™ Esophageal | Boston Scientific Corporation | 24 |
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.