Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Coch
Summary
Cochlear received 510(k) clearance for Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App, a PFO device. Cleared on 2023-08-18.
Details
Source
510(k) Clearance
External ID
K231204
Action Date
2023-08-18
Status
Traditional
Category
device
Product Code
PFO
Product Description
Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App. Product code: PFO.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Cochlear has received 3 total clearances in our database.
Cochlear has 3 FDA actions in our database, including 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Cochlear have FDA actions?
Cochlear has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231204" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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