K260119

Substantially Equivalent

SpaceOAR Vue System (SV-2101)

Applicant: Boston Scientific Corporation
Product code: OVB
Advisory panel: Radiology
Date received: 2026-01-14
Decision date: 2026-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Marborough, MA, US

Adverse events under product code OVB

product code OVB

Death: 7
Injury: 658
Malfunction: 1,206
Total: 1,871

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.