Fluent Fluid Management System— 510(k) K180825

Name: FDA 510(k) clearance K180825
Creator: U.S. Food and Drug Administration
Published: 2018-08-03

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K180825 for Fluent Fluid Management System, Substantially Equivalent on 2018-08-03. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code HIG
Device class: Class 2
Regulation: 21 CFR 884.1700
Advisory panel: Obstetrics/Gynecology
Date received: 2018-03-30
Decision date: 2018-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malborough, MA, US

Download summary PDF View on FDA.gov ↗

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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.