K241598
- 510(k) number
- K241598
- Device name
- LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500)
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-07-01
- Date received
- 2024-06-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K241598.pdf
Official FDA record: K241598
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.