Esophageal TTS Stent
Partially Covered Esophageal Stent System
1manufacturer
144catalogue numbers in this listing
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 | Taewoongmedical.co., Ltd. |
|---|---|
| FDA product code | ESW |
| Device type | Prosthesis, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3610 |
| 510(k) | K211706 |
| Record published | 2021-10-15 |
| Record revised | 2026-04-07 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Catheter gauge 10.5 Fr; length 6 to 15 cm; outer diameter 18 to 22 mm; stent diameter 18 to 22 mm; stent length 6 to 15 cm; catheter working length 180 to 220 cm |
| Distribution end date | 2018-06-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EST2215B-22 | Stent Diameter 22 mm | In distribution |
| EST2014B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2010B-22 | Stent Diameter 20 mm | In distribution |
| EST2015F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2008F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2008F | Outer Diameter 20 mm | In distribution |
| EST2006B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2012F-22 | Stent Diameter 20 mm | In distribution |
| EST2008B | Outer Diameter 20 mm | In distribution |
| EST2014F-22 | Stent Diameter 20 mm | In distribution |
| EST2208B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2010B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1812F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2212B-22 | Stent Diameter 22 mm | In distribution |
| EST1810F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1814F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1812B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1808B | Outer Diameter 18 mm | In distribution |
| EST2214F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1806F-22 | Stent Diameter 18 mm | In distribution |
| EST2214B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2012F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2012F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2210F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2215F | Stent Diameter 22 mm | In distribution |
| EST2210F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2214B | Stent Diameter 22 mm | In distribution |
| EST2008B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1810F-22 | Stent Diameter 18 mm | In distribution |
| EST1808B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2006F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2015B | Outer Diameter 20 mm | In distribution |
| EST2215B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2006B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2006F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1812F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1814B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2212B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2014B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2208B-22 | Stent Diameter 22 mm | In distribution |
| EST2006B-22 | Stent Diameter 20 mm | In distribution |
| EST2006B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1812F-22 | Stent Diameter 18 mm | In distribution |
| EST2012B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2015B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1806B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1815F | Outer Diameter 18 mm | In distribution |
| EST1814B-22 | Stent Diameter 18 mm | In distribution |
| EST1810B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1812B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2008F-22 | Stent Diameter 20 mm | In distribution |
| EST2006F-22 | Stent Diameter 20 mm | In distribution |
| EST1806B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2010F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1808F | Outer Diameter 18 mm | In distribution |
| EST2014B-22 | Stent Diameter 20 mm | In distribution |
| EST2010B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1812B | Outer Diameter 18 mm | In distribution |
| EST2014B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1808F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2008F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1815F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2206F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2014F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2206F | Stent Diameter 22 mm | In distribution |
| EST1814B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2206F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2015F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2208B | Stent Diameter 22 mm | In distribution |
| EST2210F-22 | Stent Diameter 22 mm | In distribution |
| EST2214B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2206B-22 | Stent Diameter 22 mm | In distribution |
| EST1808B-22 | Stent Diameter 18 mm | In distribution |
| EST2208F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2210B | Stent Diameter 22 mm | In distribution |
| EST2212B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2210B-22 | Stent Diameter 22 mm | In distribution |
| EST2208B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2212F | Stent Diameter 22 mm | In distribution |
| EST1814F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2206F-22 | Stent Diameter 22 mm | In distribution |
| EST1815F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2010F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1810F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1810B-22 | Stent Diameter 18 mm | In distribution |
| EST2212F-22 | Stent Diameter 22 mm | In distribution |
| EST2010B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2214F | Stent Diameter 22 mm | In distribution |
| EST2206B | Stent Diameter 22 mm | In distribution |
| EST2206B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2015F | Outer Diameter 20 mm | In distribution |
| EST2208F | Stent Diameter 22 mm | In distribution |
| EST2215F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2210F | Stent Diameter 22 mm | In distribution |
| EST2215F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2012B | Outer Diameter 20 mm | In distribution |
| EST2215F-22 | Stent Diameter 22 mm | In distribution |
| EST2210B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2214F-22 | Stent Diameter 22 mm | In distribution |
| EST1806F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1808B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1806B-22 | Stent Diameter 18 mm | In distribution |
| EST2208F-22 | Stent Diameter 22 mm | In distribution |
| EST1814B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1806F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2008B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1806F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2014F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1814F-22 | Stent Diameter 18 mm | In distribution |
| EST1815B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1815F-22 | Stent Diameter 18 mm | In distribution |
| EST2212F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2212B | Stent Diameter 22 mm | In distribution |
| EST2015B-22 | Stent Diameter 20 mm | In distribution |
| EST2012B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1808F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2215B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1810F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1815B | Outer Diameter 18 mm | In distribution |
| EST2010F-22 | Stent Diameter 20 mm | In distribution |
| EST2012B-22 | Stent Diameter 20 mm | In distribution |
| EST1815B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1806B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1808F-22 | Stent Diameter 18 mm | In distribution |
| EST2015F-22 | Stent Diameter 20 mm | In distribution |
| EST1815B-22 | Stent Diameter 18 mm | In distribution |
| EST2208F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1810B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2006F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST1812F | Outer Diameter 18 mm | In distribution |
| EST1814F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2212F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2214F | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2215B | Stent Diameter 22 mm | In distribution |
| EST2010F-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST1812B-22 | Stent Diameter 18 mm | In distribution |
| EST2008B-22 | Stent Diameter 20 mm | In distribution |
| EST1810B | Catheter Usable Length: 180 Centimeter | In distribution |
| EST2012F | Outer Diameter 20 mm | In distribution |
| EST2214B-22 | Stent Diameter 22 mm | In distribution |
| EST2210B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2015B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2206B-22 | Catheter Usable Length: 220 Centimeter | In distribution |
| EST2014F | Catheter Usable Length: 180 Centimeter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hilzo Esophageal stents | BCM Co., Ltd. | 464 |
| 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 |
| Ultraflex™ Esophageal NG | Boston Scientific Corporation | 19 |
Showing 12 of 20. All products under Prosthesis, Esophageal
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Taewoong Medical Co., Ltd. | 510(k) number | 2019-10-18 | Class II | Error in labeling | Misprinted IFUs shipped with esophageal stents | 178 | 2021-10-15 |
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.