Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
Summary
Blue Sky Bio, LLC received 510(k) clearance for Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G, a NXC device. Cleared on 2023-02-24.
Details
Source
510(k) Clearance
External ID
K221845
Action Date
2023-02-24
Status
Abbreviated
Category
device
Product Code
NXC
Product Description
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G. Product code: NXC.
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. Blue Sky Bio, LLC has received 3 total clearances in our database.
Blue Sky Bio, LLC 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 Blue Sky Bio, LLC have FDA actions?
Blue Sky Bio, LLC 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 "K221845" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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