Fluent Pro Procedure Kit
Fluent Pro Procedure Kit supplies the fluid tubing and waste collection components used with the Fluent Pro hysteroscopy console. It contains sterile In-FloPak inflow and Out-FloPak outflow…
Fluent Pro Procedure Kit supplies the fluid tubing and waste collection components used with the Fluent Pro hysteroscopy console. It contains sterile In-FloPak inflow and Out-FloPak outflow tube sets plus a nonsterile waste bag. The kit is intended for single use.
The tubing connects the fluid pathway during diagnostic or operative hysteroscopy. The separate console controls inflow and outflow for uterine liquid distension and monitors the difference between fluid delivered and recovered. The disposable kit carries that flow rather than providing the console’s motors or pressure display.
System Compatibility
Fluent Pro also supplies drive, control and suction for compatible MyoSure tissue-removal devices through the console and foot pedal. The procedure kit supports fluid delivery and collection within that system; its sterile tubing and nonsterile waste bag have different supply conditions.
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) | K240886 |
| Record published | 2024-10-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FLT-212S | 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.