Endura Ureteral Stent and Stent Set— 510(k) K251469

Name: FDA 510(k) clearance K251469
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Unknown

Cathegenix (Xiamen) Co., Ltd.

FDA 510(k) clearance K251469 for Endura Ureteral Stent and Stent Set, Unknown on 2025-12-19. Applicant: Cathegenix (Xiamen) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Cathegenix (Xiamen) Co., Ltd.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 2025-05-13
Decision date: 2025-12-19
Decision: Unknown
Clearance type: Traditional
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAD

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K251890 — Disposable Ureteral Stents2026-02-20
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

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K250585 — LumenaTM Ureteral Access Sheath2025-06-27

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.