510(k) K260428 · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
RIVOS EUS Access Device (M00553900)
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Jun 17, 2026 |
| Received | Feb 10, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260428
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.