EndoMAXX®
EndoMAXX®: 24 catalogue numbers listed by Merit Medical Systems, Inc., United States, under Prosthesis, Esophageal. 1 manufacturer in China is registered for this product code.
1manufacturer
24catalogue 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 | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | ESW |
| Device type | Prosthesis, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3610 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2024-02-23 |
| Record revised | 2025-04-21 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E | Expanded Stent Length (mm)-150 mm | In distribution |
| 00884450442357 | Nominal Stent Diameter (mm)-23 mm | In distribution |
| 00884450442234 | Nominal Stent Diameter (mm)-19 mm | In distribution |
| 00884450442272 | Expanded Stent Length (mm)-150 mm | In distribution |
| 00884450147627 | Nominal Stent Diameter (mm)-23 mm | In distribution |
| 00884450442296 | Nominal Stent Diameter (mm)-19 mm | In distribution |
| 00884450442333 | Nominal Stent Diameter (mm)-23 mm | In distribution |
| E | Nominal Stent Diameter (mm)-23 mm | In distribution |
| 00884450093108 | Expanded Stent Length (mm)-70 mm | In distribution |
| 00884450093085 | Nominal Stent Diameter (mm)-19 mm | In distribution |
| E | Nominal Stent Diameter (mm)-19 mm | In distribution |
| E | Expanded Stent Length (mm)-100 mm | In distribution |
| 00884450442371 | Nominal Stent Diameter (mm)-23 mm | In distribution |
| E | Expanded Stent Length (mm)-70 mm | In distribution |
| 00884450093061 | Nominal Stent Diameter (mm)-19 mm | In distribution |
| 00884450093047 | Expanded Stent Length (mm)-100 mm | In distribution |
| 00884450442319 | Nominal Stent Diameter (mm)-23 mm | In distribution |
| E | Nominal Stent Diameter (mm)-23 mm | In distribution |
| 00884450147634 | Expanded Stent Length (mm)-120 mm | In distribution |
| 00884450147641 | Expanded Stent Length (mm)-150 mm | In distribution |
| 00884450442258 | Nominal Stent Diameter (mm)-19 mm | In distribution |
| 00884450147610 | Nominal Stent Diameter (mm)-23 mm | In distribution |
| E | Expanded Stent Length (mm)-70 mm | In distribution |
| E | Expanded Stent Length (mm)-150 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 |
| 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 |
| 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 |
|---|---|
| K251265 | 2025-07-23 |
| K111611 | 2011-07-29 |
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.