K250270
- 510(k) number
- K250270
- Device name
- Luja Set
- Applicant
- Coloplast Corp. MN · US
- Product code
- EZD — Catheter, Straight
- Decision date
- 2025-04-17
- Date received
- 2025-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250270.pdf
Official FDA record: K250270
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.