RIVOS EUS Access Device (M00553900)— 510(k) K260428

Name: FDA 510(k) clearance K260428
Creator: U.S. Food and Drug Administration
Published: 2026-06-17

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K260428 for RIVOS EUS Access Device (M00553900), Substantially Equivalent on 2026-06-17. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code ODG
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-02-10
Decision date: 2026-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ODG

product code ODG

Death: 30
Injury: 237
Malfunction: 12,387
Other: 1
Total: 12,655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.