K260999
- 510(k) number
- K260999
- Device name
- LoFric Elle Pro
- Applicant
- Wellspect AB SE
- Product code
- EZD — Catheter, Straight
- Decision date
- 2026-04-24
- Date received
- 2026-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K260999.pdf
Official FDA record: K260999
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.