RIVOS EUS Access Device (M00553900)— 510(k) K260428
Substantially EquivalentBoston 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.
Summary
Boston Scientific's RIVOS EUS Access Device (M00553900) is filed under ODG, endoscopic ultrasound systems for gastroenterology and urology. The record doesn't expand "EUS" or describe the device beyond its name.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Boston Scientific filed from Marlboro, Massachusetts. Review took 127 calendar days (February 10 to June 17, 2026).
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Product code ODG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Recent devices under product code ODG
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code ODG
product code ODG- Death
- 30
- Injury
- 237
- Malfunction
- 12,387
- Other
- 1
- Total
- 12,655
Source: openFDA MAUDE database, through . 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.