K233645
- 510(k) number
- K233645
- Device name
- StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
- Applicant
- Boston Scientific Corporation - MA · US
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2023-12-12
- Date received
- 2023-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K233645.pdf
Official FDA record: K233645
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.