Single Use Ureteral Access Sheath— 510(k) K260410
Substantially EquivalentZhejiang Chuangxiang Medical Technology Co., Ltd.
FDA 510(k) clearance K260410 for Single Use Ureteral Access Sheath, Substantially Equivalent on 2026-09-11. Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Device class: 2.
Summary
A single-use ureteral access sheath, filed under FED (endoscopic access overtubes). The code covers devices that help pass and advance endoscopes into the body, especially with repeated intubation.
Class II, 21 CFR 876.1500, Gastroenterology and Urology panel. Zhejiang Chuangxiang Medical Technology filed it as a Special 510(k).
The company filed from Hangzhou, China. Its clock ran 214 days (February 9 to September 11, 2026).
Clearance details
- Applicant
- Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Product code
- Product code FED
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hangzhou, CN
Recent devices under product code FED
view allMore clearances from Zhejiang Chuangxiang Medical Technology Co., Ltd.
view allAdverse events under product code FED
product code FED- Death
- 10
- Total
- 10
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.