Aquilex Fluid Control System
4 catalogue numbers from AQL-100PBS, listed by W.O.M. World of Medicine GmbH, United States, under Insufflator, Hysteroscopic. 1 manufacturer in China is registered for this product code.
1manufacturer
4catalogue numbers in this listing
10510(k) clearances naming this product code
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) | K172040 |
| Record published | 2018-06-26 |
| Record revised | 2022-12-05 (version 4) |
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 |
|---|---|---|
| AQL-100PBS | In distribution | |
| AQL-100P | In distribution | |
| AQL-100CS | In distribution | |
| AQL-100CBS | 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 |
| 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 |
| 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
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Novanta Medical GmbH | 510(k) number | 2023-07-17 | Class II | Software design | The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid | 1287 units | |
| Novanta Medical GmbH | 510(k) number | 2019-08-14 | Class II | Nonconforming Material/Component | The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. | 322 units | 2020-05-20 |
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.