Fluent Fluid Management System
The Fluent Fluid Management System distends the uterus with liquid during diagnostic and operative hysteroscopy. It also tracks the difference between irrigation fluid entering and leaving…
The Fluent Fluid Management System distends the uterus with liquid during diagnostic and operative hysteroscopy. It also tracks the difference between irrigation fluid entering and leaving the uterus and provides drive, control and suction for compatible hysteroscopic morcellators.
The console controls inflow and outflow with motors and monitors pressure through a sensor system. A touchscreen presents the user interface. Single use inflow and outflow tube sets and a waste bag connect the console to the procedure’s fluid pathway.
Listed Item
The Fluent® Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators
Tissue Removal Controls
The console connects to compatible MyoSure Tissue Removal Devices and a pneumatic foot pedal for tissue removal procedures. A fluid deficit alert and an overpressure protection mechanism support fluid management during use. The procedure kit combines sterile tube sets with a nonsterile waste bag.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | HIG |
| Device type | Insufflator, Hysteroscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1700 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180825 |
| Record published | 2023-12-19 |
| Record revised | 2023-08-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box, carton of 4, carton of 6 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FLT-010 | 10 | In distribution | |
| FLT-112S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tube set for irrigation, single-use | W.O.M. World of Medicine GmbH | 9 |
| Insufflator, Hysteroscopic | Karl Storz GmbH & Co. KG | 7 |
| Aquilex Fluid Control System | W.O.M. World of Medicine GmbH | 4 |
| Aveta Smol Disposable Resecting Device, 2.9 mm | Meditrina, Inc. | 4 |
| Tube set for suction, single-use | W.O.M. World of Medicine GmbH | 4 |
| Premier | Premier Dental Products Co. | 3 |
| Fluid Safe | Stryker GmbH | 3 |
| Insufflator, Hysteroscopic | Covidien LP | 3 |
| Hysteroscopic Fluid Management | Smith & Nephew, Inc. | 3 |
| Aveta Disposable Resecting Handset | Meditrina, Inc. | 2 |
| Fluid Monitoring Unit | W.O.M. World of Medicine GmbH | 2 |
| Conmed | ConMed Corporation | 2 |
Showing 12 of 58. All products under Insufflator, Hysteroscopic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240886 | 2024-07-25 |
| K180825 | 2018-08-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.