Silicone Urethral Catheter (Silicone Urethral Catheter)— 510(k) K243011

Name: FDA 510(k) clearance K243011
Creator: U.S. Food and Drug Administration
Published: 2025-06-16

Substantially Equivalent

Guangdong Ecan Medical Co., Ltd.

FDA 510(k) clearance K243011 for Silicone Urethral Catheter (Silicone Urethral Catheter), Substantially Equivalent on 2025-06-16. Applicant: Guangdong Ecan Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangdong Ecan Medical Co., Ltd.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-26
Decision date: 2025-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EZL

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K260756 — TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)2026-09-04
K262056 — Rusch Latex Gold Foley Catheter2026-08-05
K252537 — Rusch SoftSimplastic Foley Catheters2026-01-20
K241424 — InnoCare Specialty Foley Catheter2024-09-18
K232469 — Rüsch Latex Gold Foley Catheter2024-08-01

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.