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 disposable ureteral access sheath, filed under FED (endoscopic access overtubes). Urologists place the sheath up into the ureter during ureteroscopy so scopes and stone baskets can go in and out repeatedly without scraping the same tissue on every pass.
Class II, 21 CFR 876.1500, Gastroenterology and Urology panel. It's a Special 510(k), so Zhejiang Chuangxiang Medical Technology was changing a sheath it already had cleared.
The company filed from Hangzhou, China. Its 214-day clock (February 9 to September 11, 2026) is long for a Special. The pathway assumes a small, contained change, and seven months usually means FDA wanted more testing than the applicant brought.
Clearance details
- Applicant
- Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Product code
- 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.