Cleared Traditional

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)

K240886 · Hologic, Inc. · Obstetrics & Gynecology

Jul 2024

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K240886 is an FDA 510(k) clearance for the 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), a Insufflator, Hysteroscopic (Class II — Special Controls, product code HIG), submitted by Hologic, Inc. (Marlborough, US). The FDA issued a Cleared decision on July 25, 2024, 115 days after receiving the submission on April 1, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1700.

Submission Details

510(k) Number	K240886 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2024
Decision Date	July 25, 2024
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF