Fluent Console
The Fluent console manages irrigation fluid during diagnostic and operative hysteroscopy. It supplies liquid to distend the uterus and tracks the difference between the fluid entering and…
The Fluent console manages irrigation fluid during diagnostic and operative hysteroscopy. It supplies liquid to distend the uterus and tracks the difference between the fluid entering and leaving it. The console also provides the drive, control and suction needed by compatible MyoSure hysteroscopic tissue removal devices.
Motors operate the inflow and outflow pumps, while a pressure sensing system monitors the fluid delivery. The console connects to an In-FloPak inflow set, an Out-FloPak outflow set and a waste bag. A touchscreen provides the operator interface, and a pneumatic foot pedal activates tissue removal.
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
Monitoring and Accessories
The console includes fluid deficit alerts and protection against excessive pressure. The procedure tubing sets are sterile and for a single use; the waste bag is nonsterile. These components connect to the console to form the fluid pathway used during the procedure.
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 | 2018-08-31 |
| Record revised | 2023-08-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 560 to 760 Millimeter of Mercury; Storage environment temperature -10 to 60 °C; Handling environment humidity 20 to 80 % RH; Storage environment humidity 10 to 80 % RH; Handling environment atmospheric pressure 560 to 760 Millimeter of Mercury; Handling environment temperature 15 to 30 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FLT-100 | 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 |
| Fluent Fluid Management System | Hologic, Inc. | 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.