Cranial EM System
Summary
Brainlab AG received 510(k) clearance for Cranial EM System, a HAW device. Cleared on 2022-09-08.
Details
Source
510(k) Clearance
External ID
K213989
Action Date
2022-09-08
Status
Traditional
Category
device
Product Code
HAW
Product Description
Cranial EM System. Product code: HAW.
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. Brainlab AG has received 28 total clearances in our database.
Brainlab AG has 32 FDA actions in our database, including 4 recalls and 28 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 Brainlab AG have FDA actions?
Brainlab AG has 32 FDA actions in our database, including 4 recalls and 28 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213989" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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