Mpathy Medical Devices, Ltd.
Country not established
- Devices
- 7
What Mpathy Medical Devices, Ltd. makes
Mpathy Medical Devices, Ltd. manufactures polypropylene mesh products for pelvic floor repair, including modified Minimesh mesh and Restorelle mesh, as well as urethral sling systems like the Minitape, Minitape Extra, and Omnisure (Model OTK52) for stress urinary incontinence treatment.
The company’s portfolio includes devices classified as Class II and Class III under FDA regulations, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Modification To: Minimesh Polypropylene Mesh Ref K053361
Regimes: 510(k) Registry: 510(k)Minitape Urethral Sling Ref K091180
Regimes: 510(k) Registry: 510(k)Restorelle Polypropylene Mesh Ref K092207
Regimes: 510(k) Registry: 510(k)Minimesh Polypropylene Mesh Ref K041632
Regimes: 510(k) Registry: 510(k)Minitape Urethral Sling Ref K073646
Regimes: 510(k) Registry: 510(k)Minitape Extra Urethral Sling Ref K073647
Regimes: 510(k) Registry: 510(k)Omnisure Urethral Sling, Model OTK52 Ref K092203
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mpathy Medical Devices, Ltd. have in the registry?
The registry currently lists 7 devices for Mpathy Medical Devices, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mpathy Medical Devices, Ltd.'s devices?
Among its 7 most recently registered devices, Mpathy Medical Devices, Ltd. has devices listed in FDA 510(k) (7 devices).
What risk classes do Mpathy Medical Devices, Ltd.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Mpathy Medical Devices, Ltd.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Mpathy Medical Devices, Ltd. in the registry?
The most recently registered devices listed for Mpathy Medical Devices, Ltd. include MODIFICATION TO: MINIMESH POLYPROPYLENE MESH, MINITAPE URETHRAL SLING, RESTORELLE POLYPROPYLENE MESH and MINIMESH POLYPROPYLENE MESH.