DeviceClearance

Fluent Pro Fluid Management System (FLT-200) +4 more— 510(k) K240886

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K240886 for Fluent Pro Fluid Management System (FLT-200) +4 more, Substantially Equivalent on 2024-07-25. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Device name as filed
Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)
Applicant
Hologic, Inc.
Product code
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
Malborough, MA, US
Download summary PDFView 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, 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.