Cleared Traditional

Disposable Ureteral Stents

K251890 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology
Feb 2026
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K251890 is an FDA 510(k) clearance for the Disposable Ureteral Stents, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 20, 2026, 245 days after receiving the submission on June 20, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.

Submission Details

510(k) Number K251890 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2025
Decision Date February 20, 2026
Days to Decision 245 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FAD — Stent, Ureteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4620

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