Asurys Fluid Management System— 510(k) K251273

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K251273 for Asurys Fluid Management System, Substantially Equivalent on 2026-03-27. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 2025-04-24
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.