Single Use Ureteral Access Sheath
The Single Use Ureteral Access Sheath provides a working channel for passing endoscopes during urologic endoscopic procedures. It also provides ureteral dilation during access. The assembly…
The Single Use Ureteral Access Sheath provides a working channel for passing endoscopes during urologic endoscopic procedures. It also provides ureteral dilation during access. The assembly consists of an outer sheath, sheath base, dilator tube, locking clip and joint.
A hydrophilic coating covers the sheath’s outer surface. Once activated, the coating assists insertion and removal. The range has sheath inner diameters of 10, 12 and 14 Fr and effective lengths from 10 to 55 cm.
Sterile Supply
Each device is supplied in its own peel-open pouch and sterilized with ethylene oxide. It is intended for a single procedure, with a stated shelf life of two years. Available effective lengths include 10, 16.5, 20, 25, 35, 45 and 55 cm.
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 Chuangxiang 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 | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K220065 |
| Record published | 2023-05-24 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MD-A-AS-1035 | In distribution | |
| MD-B-AS-1255 | In distribution | |
| MD-B-AS-1425 | In distribution | |
| MD-B-AS-1220 | In distribution | |
| MD-B-AS-1055 | In distribution | |
| MD-B-AS-1016 | In distribution | |
| MD-A-AS-1216 | In distribution | |
| MD-A-AS-1425 | In distribution | |
| MD-A-AS-1416 | In distribution | |
| MD-A-AS-1220 | In distribution | |
| MD-A-AS-1420 | In distribution | |
| MD-A-AS-1235 | In distribution | |
| MD-B-AS-1245 | In distribution | |
| MD-B-AS-1035 | In distribution | |
| MD-A-AS-1445 | In distribution | |
| MD-A-AS-1245 | In distribution | |
| MD-B-AS-1020 | In distribution | |
| MD-B-AS-1445 | In distribution | |
| MD-A-AS-1020 | In distribution | |
| MD-B-AS-1045 | In distribution | |
| MD-A-AS-1255 | In distribution | |
| MD-B-AS-1420 | In distribution | |
| MD-A-AS-1045 | In distribution | |
| MD-B-AS-1435 | In distribution | |
| MD-B-AS-1235 | In distribution | |
| MD-B-AS-1216 | In distribution | |
| MD-A-AS-1225 | In distribution | |
| MD-B-AS-1025 | In distribution | |
| MD-A-AS-1016 | In distribution | |
| MD-B-AS-1416 | In distribution | |
| MD-A-AS-1055 | In distribution | |
| MD-A-AS-1025 | In distribution | |
| MD-B-AS-1225 | In distribution | |
| MD-A-AS-1435 | In distribution | |
| MD-B-AS-1455 | 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 | 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 |
| 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 |
|---|---|
| K220065 | 2022-05-25 |
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.