K252537
- 510(k) number
- K252537
- Device name
- Rusch SoftSimplastic Foley Catheters
- Applicant
- Teleflex Medical Sdn. Bhd. MY
- Product code
- EZL — Catheter, Retention Type, Balloon
- Decision date
- 2026-01-20
- Date received
- 2025-08-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252537.pdf
Official FDA record: K252537
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.