Myosure XL Hysteroscopy SET
The MyoSure XL Rod Lens Hysteroscope provides a view of the cervical canal and uterine cavity for diagnostic and surgical procedures. Its stainless steel tube contains an optical lens train…
The MyoSure XL Rod Lens Hysteroscope provides a view of the cervical canal and uterine cavity for diagnostic and surgical procedures. Its stainless steel tube contains an optical lens train and a working channel, allowing observation and instrument access through the scope.
A distal objective lens collects the image, and rod lenses relay it to an offset eyepiece. An ocular lens forms the image for the eye or camera. Glass fibers provide illumination, and an inflow channel with a stopcock delivers fluid.
Working Channel
The 4 mm working channel accepts a removable outflow channel. A proximal seal limits distension-fluid leakage while allowing insertion of handheld instruments or cautery probes. The hysteroscope must be sterilized before use.
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (4), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Ningbo Skonsin Electronics Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Shanghai AnQing Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Guangdong EO Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
| Suzhou Acuvu Medical Technology Co., Ltd. | Suzhou | Jiangsu | Specification developer | 4 |
| Jiangsu Jiyuan Medical Technology Co., Ltd. | Taizhou | Jiangsu | Specification developer | 3 |
Showing 12 of 13. All 13 manufacturers in China registered for Hysteroscope (And Accessories)
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | HIH |
| Device type | Hysteroscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1690 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K122563 |
| Record published | 2018-10-03 |
| Record revised | 2024-06-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date |
| Storage | Storage environment temperature -29 to 50 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50-250XL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hysteroscope (And Accessories) | Karl Storz GmbH & Co. KG | 255 |
| AED | National Advanced Endoscopy Devices, Inc. | 79 |
| USA Elite | Gyrus Acmi, Inc. | 79 |
| Olympus | Olympus Winter & IBE Gmbh | 57 |
| Hysteroscope (And Accessories) | Stryker GmbH | 42 |
| TruClear | Covidien LP | 29 |
| Hysteroscopy sheath | Sopro-Comeg GmbH | 28 |
| Hysteroscope (And Accessories) | Richard Wolf Gmbh | 24 |
| Hysteroscope | Sopro-Comeg GmbH | 18 |
| Elite 2 System | Gyrus Acmi, Inc. | 17 |
| Gynecare Versapoint | Ethicon, Inc. | 16 |
| USA Elite System | Gyrus Acmi, Inc. | 11 |
Showing 12 of 177. All products under Hysteroscope (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191281 | 2019-08-29 |
| K182006 | 2018-12-06 |
| K181974 | 2018-08-23 |
| K173901 | 2018-05-08 |
| K172566 | 2017-09-20 |
| K152723 | 2015-11-13 |
| K142029 | 2014-11-26 |
| K131736 | 2013-08-22 |
| K131581 | 2013-08-22 |
| K122563 | 2012-09-19 |
| K122498 | 2012-09-10 |
| K121868 | 2012-07-19 |
| K120593 | 2012-03-23 |
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.