Hysteroscopic Roller Base
RFB Roller Base Hyster Fluid Mgmt SYS
1manufacturer
2catalogue numbers in this listing
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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HIG |
| Device type | Insufflator, Hysteroscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1700 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K031616 |
| Record published | 2017-10-24 |
| Record revised | 2023-09-07 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7210166F | In distribution | |
| 7210166 | Withdrawn |
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
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.