Hanarostent® Esophagus (CCC)
44 catalogue numbers from HES-A-20-080-070, listed by M.I.Tech Co Ltd, South Korea, under Prosthesis, Esophageal. 1 manufacturer in China is registered for this product code.
1manufacturer
44catalogue numbers in this listing
6510(k) clearances naming this product code
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 | 2022-11-28 (version 4) |
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; length 80 to 170 mm; lumen/inner diameter 18 to 22 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HES-A-20-080-070 | Stent Diameter 20 mm | In distribution |
| HES-A-18-150-070 | Stent Diameter 18 mm | In distribution |
| HES-22-100-070 | 700mm | In distribution |
| HES-22-160-070 | 700MM | In distribution |
| HES-A-18-090-070 | Stent Diameter 18 mm | In distribution |
| HES-18-160-070 | 700mm | In distribution |
| HES-22-150-070 | 700MM | In distribution |
| HES-A-22-130-070 | Stent Diameter 22 mm | In distribution |
| HES-22-080-070 | 700mm | In distribution |
| HES-A-22-080-070 | Stent Diameter 22 mm | In distribution |
| HES-A-22-140-070 | Stent Diameter 22 mm | In distribution |
| HES-A-20-090-070 | Stent Diameter 20 mm | In distribution |
| HES-A-18-130-070 | Stent Diameter 18 mm | In distribution |
| HES-22-140-070 | 700MM | In distribution |
| HES-18-090-070 | 700MM | In distribution |
| HES-A-20-100-070 | Stent Diameter 20 mm | In distribution |
| HES-A-18-100-070 | Stent Diameter 18 mm | In distribution |
| HES-A-18-120-070 | Stent Diameter 18 mm | In distribution |
| HES-22-110-070 | 700MM | In distribution |
| HES-A-20-140-070 | Stent Diameter 20 mm | In distribution |
| HES-A-22-100-070 | Stent Diameter 22 mm | In distribution |
| HES-18-110-070 | 700MM | In distribution |
| HES-22-120-070 | 700MM | In distribution |
| HES-A-20-150-070 | Stent Diameter 20 mm | In distribution |
| HES-A-22-150-070 | Stent Diameter 22 mm | In distribution |
| HES-A-22-120-070 | Stent Diameter 22 mm | In distribution |
| HES-18-080-070 | 700mm | In distribution |
| HES-A-18-110-070 | Stent Diameter 18 mm | In distribution |
| HES-22-130-070 | 700MM | In distribution |
| HES-A-20-110-070 | Stent Diameter 20 mm | In distribution |
| HES-22-090-070 | 700mm | In distribution |
| HES-18-140-070 | 700mm | In distribution |
| HES-22-170-070 | 700MM | In distribution |
| HES-A-18-140-070 | Stent Diameter 18 mm | In distribution |
| HES-A-20-130-070 | Stent Diameter 20 mm | In distribution |
| HES-18-130-070 | 700mm | In distribution |
| HES-A-22-110-070 | Stent Diameter 22 mm | In distribution |
| HES-18-120-070 | 700MM | In distribution |
| HES-A-20-120-070 | Stent Diameter 20 mm | In distribution |
| HES-A-18-080-070 | Stent Diameter 18 mm | In distribution |
| HES-18-150-070 | 700mm | In distribution |
| HES-18-170-070 | 700mm | In distribution |
| HES-18-100-070 | 700MM | In distribution |
| HES-A-22-090-070 | Stent Diameter 22 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 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 |
| 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.