Fluid Monitoring Unit
The FDA filing identifies PS304 as the Fluid Monitoring Unit used with the GYN-Pump PH304 and explicitly calls it a component of that system. Its role is to measure fluid inflow for…
The FDA filing identifies PS304 as the Fluid Monitoring Unit used with the GYN-Pump PH304 and explicitly calls it a component of that system.
Its role is to measure fluid inflow for fluid-deficit monitoring during hysteroscopy, using a separate weighing cell for fluid bags.
Monitoring Method
The submission says the PS304 weighing cell directly weighs the fluid bags to measure inflow volume. It reports a 6 percent accuracy for fluid-deficit measurement with this method.
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 | W.O.M. World of Medicine GmbH, United States |
|---|---|
| FDA product code | HIG |
| Device type | Insufflator, Hysteroscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1700 |
| 510(k) | K173489 |
| Record published | 2018-04-16 |
| Record revised | 2018-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS304 | In distribution | |
| PS304 | 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 |
| Fluent Fluid Management System | Hologic, Inc. | 2 |
| Conmed | ConMed Corporation | 2 |
Showing 12 of 58. All products under Insufflator, Hysteroscopic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173489 | 2018-03-28 |
| K172040 | 2018-02-05 |
| K123732 | 2013-04-04 |
| K112642 | 2012-02-06 |
| K031616 | 2003-08-13 |
| K022449 | 2003-04-10 |
| K983889 | 1999-01-14 |
| K934866 | 1995-10-20 |
| K933847 | 1995-08-15 |
| K924523 | 1995-04-11 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Novanta Medical GmbH | 510(k) number | 2021-06-18 | Class II | Software design | When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the | 1100 |
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.