Cochlear Osia System
K-Number: K240155 · 2024-04-18
Device Summary
Frequently Asked Questions
What is the Cochlear Osia System?
Cochlear Osia System is a medical device that received FDA 510(k) clearance on 2024-04-18. The listed applicant is Cochlear Americas. The 510(k) number is K240155.
When did Cochlear Osia System receive FDA 510(k) clearance?
Cochlear Osia System received FDA 510(k) clearance on 2024-04-18, under 510(k) number K240155.
Who is the listed applicant for Cochlear Osia System?
The FDA 510(k) record lists Cochlear Americas as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cochlear Osia System?
The FDA product code for Cochlear Osia System is PFO.
Other records listing Cochlear Americas as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: PFO)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.