Z-Stent
Z-Stent Esophageal with Dua Anti-Reflux Valve
1manufacturer
4catalogue numbers in this listing
2510(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 | Cook Incorporated, United States |
|---|---|
| FDA product code | ESW |
| Device type | Prosthesis, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3610 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-11-03 |
| Record revised | 2023-07-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place |
| Distribution end date | 2016-12-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G24872 | Withdrawn | |
| G24869 | Withdrawn | |
| G24871 | Withdrawn | |
| G24870 | Withdrawn |
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 |
|---|---|
| K945201 | 1995-01-04 |
| K914029 | 1991-12-09 |
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.