Esophageal Stent System
Micro-Tech's Esophageal Stent System places a self-expanding nitinol stent in the esophagus to maintain passage through a malignant narrowing or seal an associated fistula. The stent is…
Micro-Tech’s Esophageal Stent System places a self-expanding nitinol stent in the esophagus to maintain passage through a malignant narrowing or seal an associated fistula. The stent is supplied preloaded in a delivery system.
The woven metal mesh has enlarged ends and a silicone covering over the body and part or all of the flanges. Partially covered and fully covered versions are available. The covering limits tissue growth through the mesh and provides the sealing surface.
Listed Item
Double cup 18×100, partially covered stent with 6.7mm outer sheath,650mm working length delivery system
Placement Features
The delivery handle releases the stent by withdrawing its sheath and allows recapture during deployment. Marker bands at both ends support fluoroscopic positioning, and a lasso loop allows repositioning during initial placement. The system is supplied sterile for single use, with different stent diameters and lengths.
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 | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | ESW |
| Device type | Prosthesis, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3610 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K172813 |
| Record published | 2023-06-28 |
| Record revised | 2025-12-12 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Stent diameter 18 to 22 mm; stent length 60 to 150 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NST01-224-20.120 | Stent Diameter 20 mm | In distribution |
| NST01-222-20.060 | Stent Diameter 20 mm | In distribution |
| NST01-224-20.150 | Stent Diameter 20 mm | In distribution |
| NST01-222-22.150 | Stent Diameter 22 mm | In distribution |
| NST01-224-18.140 | Stent Diameter 18 mm | In distribution |
| NST01-222-22.120 | Stent Diameter 22 mm | In distribution |
| NST01-222-18.140 | Stent Diameter 18 mm | In distribution |
| NST01-224-20.080 | Stent Diameter 20 mm | In distribution |
| NST01-222-22.080 | Stent Diameter 22 mm | In distribution |
| NST01-222-18.150 | Stent Diameter 18 mm | In distribution |
| NST01-222-18.100 | Stent Diameter 18 mm | In distribution |
| NST01-224-22.080 | Stent Diameter 22 mm | In distribution |
| NST01-224-22.120 | Stent Diameter 22 mm | In distribution |
| NST01-222-22.100 | Stent Diameter 22 mm | In distribution |
| NST01-222-18.120 | Stent Diameter 18 mm | In distribution |
| NST01-224-18.060 | Stent Diameter 18 mm | In distribution |
| NST01-224-20.100 | Stent Diameter 20 mm | In distribution |
| NST01-224-22.140 | Stent Diameter 22 mm | In distribution |
| NST01-222-20.150 | Stent Diameter 20 mm | In distribution |
| NST01-222-22.140 | Stent Diameter 22 mm | In distribution |
| NST01-224-18.080 | Stent Diameter 18 mm | In distribution |
| NST01-224-20.140 | Stent Diameter 20 mm | In distribution |
| NST01-222-22.060 | Stent Diameter 22 mm | In distribution |
| NST01-222-18.080 | Stent Diameter 18 mm | In distribution |
| NST01-224-22.100 | Stent Diameter 22 mm | In distribution |
| NST01-224-18.120 | Stent Diameter 18 mm | In distribution |
| NST01-222-20.120 | Stent Diameter 20 mm | In distribution |
| NST01-224-22.150 | Stent Diameter 22 mm | In distribution |
| NST01-222-18.060 | Stent Diameter 18 mm | In distribution |
| NST01-224-18.100 | Stent Diameter 18 mm | In distribution |
| NST01-222-20.100 | Stent Diameter 20 mm | In distribution |
| NST01-224-20.060 | Stent Diameter 20 mm | In distribution |
| NST01-222-20.140 | Stent Diameter 20 mm | In distribution |
| NST01-224-18.150 | Stent Diameter 18 mm | In distribution |
| NST01-222-20.080 | Stent Diameter 20 mm | In distribution |
| NST01-224-22.060 | 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 (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 |
| 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 |
|---|---|
| K182910 | 2019-05-29 |
| K172813 | 2018-05-18 |
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.