YiGaoMed
"The Ureteral Access Sheath consist of an outer sheath, a tapered dilator and their sockets. The hydrophilic coating are applied to the sheath and the tip of dialtor. The ureteral access…
“The Ureteral Access Sheath consist of an outer sheath, a tapered dilator and their sockets. The hydrophilic coating are applied to the sheath and the tip of dialtor. The ureteral access sheath is used to establish a working channel during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract. This is a single-use device. A re-sterilization by users and re-use of the device are not allowed.”
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 | Zhejiang Yigao Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | FED |
| Device type | Endoscopic Access Overtube, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K250132 |
| Record published | 2025-12-09 |
| Record revised | 2025-12-10 (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 |
|---|---|---|
| AFS10040US | In distribution | |
| AFS09040US | In distribution | |
| AFS12040US | In distribution | |
| AFS10050US | In distribution | |
| AFS11050US | In distribution | |
| AFS11040US | In distribution | |
| AFS09050US | In distribution | |
| AFS12050US | 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 |
|---|---|
| K250132 | 2025-09-05 |
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.