K260428
- 510(k) number
- K260428
- Device name
- RIVOS EUS Access Device (M00553900)
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- ODG — Endoscopic Ultrasound System, Gastroenterology-Urolo
- Decision date
- 2026-06-17
- Date received
- 2026-02-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260428.pdf
Official FDA record: K260428
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.