Dornier MedTech
The Dornier MAGELLAN Ureteral Access Sheath provides a passage into the upper urinary tract during endoscopic urology procedures. It is used when ureteral dilation and access are needed for…
The Dornier MAGELLAN Ureteral Access Sheath provides a passage into the upper urinary tract during endoscopic urology procedures. It is used when ureteral dilation and access are needed for injecting fluids and passing endoscopes or related instruments. Its intended patient population is adults aged 22 years and older.
The assembly combines a dilator with a locking mechanism and a sheath with a hub. Both have hydrophilic coatings. The sheath provides a single lumen for fluid injection and repeated instrument passage, while the dilator supports placement of the access assembly.
Listed Item
Dornier Magellan Ureteral Access Sheath, 10/12Fr x 45cm
Construction and Supply
The sheath is made from medical grade thermoplastic elastomer, Pebax. It is supplied sterile as a disposable device for a single use.
Who Else Makes It
Concentrated in Guangdong (10), Shanghai (4), Zhejiang (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Seplou (Zhuhai) Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Zhejiang Yigao Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Eternal (Shanghai) Medical Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 7 |
Showing 12 of 19. All 19 manufacturers in China registered for Endoscopic Access Overtube, Gastroenterology-Urology
Record
| Listed by | Dornier Medtech America, Inc., United States |
|---|---|
| FDA product code | FED |
| Device type | Endoscopic Access Overtube, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K201815 |
| Record published | 2023-07-27 |
| Record revised | 2024-03-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Dornier Magellan Ureteral Access Sheath, 10/12Fr x 45cm | In distribution | |
| Dornier Magellan Ureteral Access Sheath, 12/14Fr x 45cm | In distribution | |
| Dornier Magellan Ureteral Access Sheath, 12/14Fr x 35cm | In distribution | |
| Dornier Magellan Ureteral Access Sheath, 10/12Fr x 25cm | In distribution | |
| Dornier Magellan Ureteral Access Sheath, 12/14Fr x 25cm | In distribution | |
| Dornier Magellan Ureteral Access Sheath, 10/12Fr x 35cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ClearPetra | Well Lead Medical Co., Ltd. | 175 |
| CoralWell | Macrolux Medical Technology Co., Ltd. | 56 |
| Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 35 |
| Single-use Ureteral Access Sheath | Shenzhen Hugemed Medical Technical Development Co., Ltd. | 25 |
| Flexor | Cook Incorporated | 25 |
| Seplou | Seplou (Zhuhai) Co., Ltd. | 24 |
| Flexor Parallel | Cook Incorporated | 21 |
| Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 20 |
| Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 18 |
| Guardus | Us Endoscopy | 16 |
| Porges Coloplast | Coloplast A/S | 14 |
| Forté® AXP Access Sheath | Applied Medical Resources Corp. | 13 |
Showing 12 of 66. All products under Endoscopic Access Overtube, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243820 | 2025-01-31 |
| K201815 | 2020-11-20 |
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.