K251116
- 510(k) number
- K251116
- Device name
- Luja Coudé
- Applicant
- Coloplast Corp. MN · US
- Product code
- EZD — Catheter, Straight
- Decision date
- 2025-06-27
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251116.pdf
Official FDA record: K251116
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.