Gynetech Pty., Ltd.
Country not established
- Devices
- 4
What Gynetech Pty., Ltd. makes
Gynetech Pty. Ltd. manufactures medical devices for minimally invasive gynecological procedures, including the McCartney Access Tube for hysteroscopic surgery and insufflation needles designed for fluid management. The company also produces manipulator tools, such as the Manipulator and Manipulator Pro, used for tissue handling and instrument positioning during hysteroscopic interventions.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States, with its products listed in the FDA’s 510(k) registry.
Catalogue
Mccartney Access Tube Ref K051594
510(k) 510(k)Manipulator; Manipulator Pro Ref K142164
510(k) 510(k)InsufflatOR Needle Ref K142700
510(k) 510(k)ManipulatOR PRO, ManipulatOR Ref K150519
510(k) 510(k)
Frequently asked questions
How many devices does Gynetech Pty., Ltd. have in the registry?
The registry currently lists 4 devices for Gynetech Pty., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gynetech Pty., Ltd.'s devices?
Among its 4 most recently registered devices, Gynetech Pty., Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Gynetech Pty., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Gynetech Pty., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gynetech Pty., Ltd. in the registry?
The most recently registered devices listed for Gynetech Pty., Ltd. include MCCARTNEY ACCESS TUBE, MANIPULATOR; MANIPULATOR PRO, InsufflatOR Needle and ManipulatOR PRO, ManipulatOR.