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)

FDA 510(k) K240886 · Hologic, Inc.

Substantially Equivalent

510(k) numberK240886

Submission

Device name
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.
Malborough, MA, US
Received
April 1, 2024
Decision date
July 25, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HIG – Insufflator, Hysteroscopic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1700
Specialty
Obstetrics/Gynecology

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K201355Endomat Select, IBS Shaver Software, LicenseHIG · Special Karl Storz SE & CO. KG07/22/2020SE
K180735Endomat SelectHIG · Traditional Karl Storz SE & CO. KG10/31/2018SE
K180825Fluent Fluid Management SystemHIG · Traditional Hologic, Inc.08/03/2018SE
K173489GYN-Pump PH304HIG · Traditional W.O.M. World of Medicine GmbH03/28/2018SE
K172040Aquilex Fluid Control System AQL-100SHIG · Special W.O.M. World of Medicine GmbH02/05/2018SE
K172048FluidSmartHIG · Special Thermedx, LLC09/05/2017SE
K133799Thermedx Fluid Managment SystemHIG · Traditional Thermedx, LLC06/20/2014SE

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Questions and answers

When was 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) cleared by the FDA?

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) received a 510(k) decision of Substantially Equivalent on July 25, 2024, 115 days after the submission was received.

What is the product code of K240886?

The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.