Single-Use Ureteral Access Sheath
The Single-use Ureteral Access Sheath creates a channel for endoscopes and instrument exchanges in the urinary tract. An inner semirigid dilator locks to the outer sheath so both advance as…
The Single-use Ureteral Access Sheath creates a channel for endoscopes and instrument exchanges in the urinary tract. An inner semirigid dilator locks to the outer sheath so both advance as one unit over a guidewire.
Both assemblies have hydrophilic coatings and are radiopaque. After the dilator is removed, the sheath’s stainless-steel reinforcement helps maintain the access lumen.
Sizes and Supply
The range provides sheath inner diameters from 10 to 14 Fr and lengths of 35 or 45 cm, with matching outer diameters. It accommodates a 0.038 inch guidewire and includes configurations supporting suction. The sheath is supplied sterile for 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 | Hunan Vathin Medical Instrument 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, Exporter |
| 510(k) | K240167 |
| Record published | 2024-11-04 |
| Record revised | 2026-04-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Intermediate package, shipping package of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UA-S1B00 | In distribution | |
| UA-S1C00 | In distribution | |
| UA-S1C02 | In distribution | |
| UA-S1D00 | In distribution | |
| UA-S1D03 | In distribution | |
| UA-S1C01 | In distribution | |
| UA-S1B03 | In distribution | |
| UA-S1A01 | In distribution | |
| UA-S1B01 | In distribution | |
| UA-S1A02 | In distribution | |
| UA-S1C03 | In distribution | |
| UA-S1800 | In distribution | |
| UA-S1A03 | In distribution | |
| UA-S1A00 | In distribution | |
| UA-S1801 | In distribution | |
| UA-S1B02 | In distribution | |
| UA-S1D02 | In distribution | |
| UA-S1802 | In distribution | |
| UA-S1803 | In distribution | |
| UA-S1D01 | 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 |
| 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 |
| Forté® HD 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 |
|---|---|
| K251599 | 2025-07-03 |
| K240167 | 2024-10-08 |
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.