Endorail System
Endorail includes two components to be used in combination called: Endorail Set and Endorail System. Endorail System is reusable and includes the following elements: • Endorail Handpiece…
Endorail includes two components to be used in combination called: Endorail Set and Endorail System. Endorail System is reusable and includes the following elements: • Endorail Handpiece (EH), • Endorail Cart (EC). Before the procedure, the operator prepares the syringe containing the ferromagnetic fluid using the Endorail Solution Syringe (ESS), the spike and the Endorail Powder (EP). The Endorail Balloon Guide (EBG) is a balloon catheter that can be introduced as needed through the endoscope instrument channel during the colonoscopy, if the procedure becomes challenging. Endorail Set does not require to be pre-mounted and does not interfere with the normal examination process. The EBG is advanced beyond the colonoscope tip where the balloon is filled with the ferromagnetic fluid and magnetically anchored with the Endorail Handpiece (EH) placed on the patient’s abdomen. Once anchored, the colonoscope can be straightened and guided along the catheter. Afterward the EBG can be unlocked, deflated and retrieved.
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (7), Shanghai (5). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
Showing 12 of 21. All 21 manufacturers in China registered for Endoscope Channel Accessory
Record
| Listed by | Endostart SRL, Italy |
|---|---|
| FDA product code | ODC |
| Device type | Endoscope Channel Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K232327 |
| Record published | 2024-10-16 |
| Record revised | 2024-12-11 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: The device must be stored in a cool and dry place |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ESYSTEMGEN2V01A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CeroFrict | SML MED-Tech Solutions Limited | 60 |
| Disposable Endoscopy Adapter Sets | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 14 |
| andorate® Biopsy Valve | GA Health Company Limited | 8 |
| andorate® 4-piece Valve Kit | GA Health Company Limited | 8 |
| Cook | Cook Incorporated | 7 |
| Water Jet Adapter | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 7 |
| andorate® 3-piece Valve Kit | GA Health Company Limited | 7 |
| Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit | GA Health Company Limited | 7 |
| Defendo Single Use Valve Kit | Medivators Inc | 6 |
| Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. (YinDu Road Factory) | 6 |
| Andorate | Smartdata Suzhou Co., Ltd. | 6 |
| BullDog® | Diversatek Healthcare Inc | 6 |
Showing 12 of 89. All products under Endoscope Channel Accessory
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.