Hanarostent® Esophagus Asymmetric (CCC)
Hanarostent Esophagus Asymmetric (CCC) is a self-expanding tubular prosthesis for malignant esophageal strictures. It is intended to maintain the esophageal lumen when narrowing is caused…
Hanarostent Esophagus Asymmetric (CCC) is a self-expanding tubular prosthesis for malignant esophageal strictures. It is intended to maintain the esophageal lumen when narrowing is caused by an intrinsic or extrinsic tumor and to occlude a concurrent esophageal fistula.
The stent is made from nickel-titanium alloy wire and is fully covered with a silicone membrane. A polymer delivery device holds it in its distal section. Pulling back the delivery device’s outer sheath allows the metal stent to expand within the esophagus.
Delivery and Single Use
The implant and its delivery device form the supplied system and are intended for single use. The asymmetric configuration has its own stent and end diameters and lengths. It retains the delivery method of the earlier esophageal CCC design, without implying the dimensions are identical across both versions.
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) | K213251 |
| 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 24 mm; stent length 80 to 150 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ECN20140-X070 | Stent Diameter 20 mm | In distribution |
| ECN20100-X070 | Stent Diameter 20 mm | In distribution |
| ECN24090-Z070 | 700 mm Delivery system | In distribution |
| ECN18090-X070 | Stent Diameter 18 mm | In distribution |
| ECN24080-Z070 | Stent Diameter 24 mm | In distribution |
| ECN24110-Z070 | 700 mm Delivery system | In distribution |
| ECN24100-Z070 | 700 mm Delivery system | In distribution |
| ECN20080-X070 | Stent Diameter 20 mm | In distribution |
| ECN20130-X070 | Stent Diameter 20 mm | In distribution |
| ECN22140-Z070 | Stent Diameter 22 mm | In distribution |
| ECN22130-Z070 | Stent Diameter 22 mm | In distribution |
| ECN20120-X070 | Stent Diameter 20 mm | In distribution |
| ECN22120-Z070 | Stent Diameter 22 mm | In distribution |
| ECN20150-X070 | Stent Diameter 20 mm | In distribution |
| ECN18080-X070 | Stent Diameter 18 mm | In distribution |
| ECN18150-X070 | Stent Diameter 18 mm | In distribution |
| ECN20090-X070 | Stent Diameter 20 mm | In distribution |
| ECN20110-X070 | Stent Diameter 20 mm | In distribution |
| ECN24130-Z070 | 700 mm Delivery system | In distribution |
| ECN18110-X070 | Stent Diameter 18 mm | In distribution |
| ECN24150-Z070 | 700 mm Delivery system | In distribution |
| ECN18140-X070 | Stent Diameter 18 mm | In distribution |
| ECN22100-Z070 | Stent Diameter 22 mm | In distribution |
| ECN22080-Z070 | Stent Diameter 22 mm | In distribution |
| ECN18130-X070 | Stent Diameter 18 mm | In distribution |
| ECN18120-X070 | Stent Diameter 18 mm | In distribution |
| ECN18100-X070 | Stent Diameter 18 mm | In distribution |
| ECN22090-Z070 | Stent Diameter 22 mm | In distribution |
| ECN24120-Z070 | 700 mm Delivery system | In distribution |
| ECN22110-Z070 | Stent Diameter 22 mm | In distribution |
| ECN22150-Z070 | Stent Diameter 22 mm | In distribution |
| ECN24140-Z070 | 700 mm Delivery system | 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 |
| 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 |
| 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.