Asurys Fluid Management System— 510(k) K251273
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K251273 for Asurys Fluid Management System, Substantially Equivalent on 2026-03-27. Applicant: Boston Scientific Corporation. Device class: 2.
Summary
Boston Scientific's Asurys Fluid Management System is filed under HIG, hysteroscopic insufflators. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 884.1700. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Boston Scientific filed from Marborough, Massachusetts, as the record spells the town. Review took 337 calendar days (April 24, 2025 to March 27, 2026).
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Product code HIG
- Device class
- Class 2
- Regulation
- 21 CFR 884.1700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marborough, MA, US
Recent devices under product code HIG
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code HIG
product code HIG- Death
- 8
- Other
- 2
- Total
- 10
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.