K261153
- 510(k) number
- K261153
- Device name
- LithoVue Elite Digital Flexible Ureteroscope System
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-08-26
- Date received
- 2026-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261153.pdf
Official FDA record: K261153
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.