Disposable Ureteral Stents— 510(k) K251890

Name: FDA 510(k) clearance K251890
Creator: U.S. Food and Drug Administration
Published: 2026-02-20

Substantially Equivalent

Zhejiang Chuangxiang Medical Technology Co., Ltd.

FDA 510(k) clearance K251890 for Disposable Ureteral Stents, Substantially Equivalent on 2026-02-20. Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Device class: 2.

Summary

Zhejiang Chuangxiang Medical Technology's Disposable Ureteral Stents are filed under product code FAD, ureteral stent. The name is generic, and the record gives no models or sizes.

Class II, 21 CFR 876.4620. Gastroenterology, Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Zhejiang Chuangxiang Medical Technology filed from Hangzhou, China. Review took 245 calendar days (June 20, 2025 to February 20, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
Product code: Product code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 2025-06-20
Decision date: 2026-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAD

view all

K251469 — Endura Ureteral Stent and Stent Set2025-12-19
K243039 — Ureteral Stents (AF-D series)2025-06-18
K243830 — Disposable ureteral stent2025-05-14
K250824 — Percuflex Ureteral Stent +11 more2025-04-15
K232920 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm2024-03-22

More clearances from Zhejiang Chuangxiang Medical Technology Co., Ltd.

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K260410 — Single Use Ureteral Access Sheath2026-09-11
K253132 — Single use stone retrieval balloons2026-03-06
K230773 — Endoscopy Irrigation Tubing2023-11-21
K231471 — Air/Water Bottle Tubing, CO2 Source Tubing2023-09-08
K220063 — Single Use Cytology Brush2022-07-28

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.