K241028
- 510(k) number
- K241028
- Device name
- Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)
- Applicant
- Coloplast MN · US
- Product code
- EZD — Catheter, Straight
- Decision date
- 2024-07-26
- Date received
- 2024-04-15
- 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: K241028.pdf
Official FDA record: K241028
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.