K243011
- 510(k) number
- K243011
- Device name
- Silicone Urethral Catheter (Silicone Urethral Catheter)
- Applicant
- Guangdong Ecan Medical Co., Ltd. CN
- Product code
- EZL — Catheter, Retention Type, Balloon
- Decision date
- 2025-06-16
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243011.pdf
Official FDA record: K243011
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.