Oti Medical, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Oti Medical, LLC makes
Oti Medical, LLC manufactures otologic surgical instruments, including the OTI Model 78-60 and OTI Model TLS-60, designed for procedures in the ear. These tools are intended for use in otological surgeries, such as cochlear implant placements or middle ear reconstructions, where precision and ergonomic handling are critical. The instruments are constructed to support minimally invasive techniques and improve surgical outcomes in specialized ear procedures.
The company’s products fall under FDA Class I and Class II classifications, indicating varying levels of regulatory oversight based on risk. These devices are listed via the FDA’s 510(k) pathway, demonstrating compliance with pre-market notification requirements. The manufacturer operates from the United States, adhering to domestic regulatory standards for medical devices.
Catalogue
Oti Model 78-60 Ref K951184
Regimes: 510(k) Registry: 510(k)Oti Model Tls-60 Ref K951437
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oti Medical, LLC have in the registry?
The registry currently lists 2 devices for Oti Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oti Medical, LLC's devices?
Among its 2 most recently registered devices, Oti Medical, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Oti Medical, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Oti Medical, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oti Medical, LLC in the registry?
The most recently registered devices listed for Oti Medical, LLC include OTI MODEL 78-60 and OTI MODEL TLS-60.