K250659
- 510(k) number
- K250659
- Device name
- LoFric Origo
- Applicant
- Wellspect AB SE
- Product code
- EZD — Catheter, Straight
- Decision date
- 2025-09-26
- Date received
- 2025-03-05
- 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: K250659.pdf
Official FDA record: K250659
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.