K262045
- 510(k) number
- K262045
- Device name
- Luja Soft
- Applicant
- Coloplast A.S. MN · US
- Product code
- EZD — Catheter, Straight
- Decision date
- 2026-07-07
- Date received
- 2026-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K262045.pdf
Official FDA record: K262045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.