HysteroBalance II
Catalogue number WA40622A, 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
1catalogue number
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) | K123732 |
| Record published | 2016-08-10 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WA40622A | 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 |
|---|---|
| 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 |
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.