Ureteral Access Sheath
Well Lead Ureteral Access Sheath establishes a working conduit for endoscopes and instruments during urological procedures. It also provides ureteral dilation during access. The assembly…
Well Lead Ureteral Access Sheath establishes a working conduit for endoscopes and instruments during urological procedures. It also provides ureteral dilation during access. The assembly consists of a sheath, dilator and connector, supplied sterile for single use.
The sheath exterior has a hydrophilic coating that assists insertion and removal once activated. Available sizes are 10, 12 and 14 Fr, with lengths from 13 to 55 cm. The 10 Fr, 20 cm configuration belongs to this range.
Listed Item
10Fr×20cm
Working Channel
The sheath maintains the passage used by endoscopes and other instruments entering the urinary tract. Its dilator and connector are distinct components of that access assembly. The coated sheath provides the conduit rather than performing stone extraction, tissue cutting or another therapeutic function itself.
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 | Well Lead Medical Co., Ltd., China |
|---|---|
| FDA product code | FED |
| Device type | Endoscopic Access Overtube, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
| 510(k) | K151084 |
| Record published | 2024-04-23 |
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 |
| Packaging | Box of 5, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| U03B011020 | In distribution | |
| U03B011455 | In distribution | |
| U03B011235 | In distribution | |
| U03B011213 | In distribution | |
| U03B011028 | In distribution | |
| U03B011228 | In distribution | |
| U03B011445 | In distribution | |
| U03B011435 | In distribution | |
| U03B011035 | In distribution | |
| U03B011255 | In distribution | |
| U03B011045 | In distribution | |
| U03B011013 | In distribution | |
| U03B011420 | In distribution | |
| U03B011428 | In distribution | |
| U03B011245 | In distribution | |
| U03B011413 | In distribution | |
| U03B011220 | In distribution | |
| U03B011055 | 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 |
| 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 |
|---|---|
| K203119 | 2020-12-09 |
| K161110 | 2016-10-12 |
| K151084 | 2016-01-07 |
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.