Kepler Medtec
Country not established
- Devices
- 2
What Kepler Medtec makes
Kepler Medtec manufactures disposable bipolar cables, designed for use in medical procedures requiring electrocautery or electrosurgical applications. These cables facilitate the connection between electrosurgical generators and active electrodes, ensuring safe and efficient energy transfer during surgical interventions.
The company’s products fall under Class II medical devices in the U.S. regulatory framework, with individual models authorised via 510(k) clearance through the FDA. The manufacturer operates from the United States, adhering to U.S. device classification and registration requirements.
Catalogue
Models 2048801-5 To 2048801-8 Ref K101660
Regimes: 510(k) Registry: 510(k)Kepler Medtec Disposable Bipolar Cable Ref K110462
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kepler Medtec have in the registry?
The registry currently lists 2 devices for Kepler Medtec. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kepler Medtec's devices?
Among its 2 most recently registered devices, Kepler Medtec has devices listed in FDA 510(k) (2 devices).
What risk classes do Kepler Medtec's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Kepler Medtec's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kepler Medtec in the registry?
The most recently registered devices listed for Kepler Medtec include MODELS 2048801-5 TO 2048801-8 and KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE.