RhinAer® Stylus (FG1393)
Summary
Aerin Medical, Inc. received 510(k) clearance for RhinAer® Stylus (FG1393), a GEI device. Cleared on 2022-07-29.
Details
Source
510(k) Clearance
External ID
K221907
Action Date
2022-07-29
Status
Special
Category
device
Product Code
GEI
Product Description
RhinAer® Stylus (FG1393). Product code: GEI.
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. Aerin Medical, Inc. has received 3 total clearances in our database.
Aerin Medical, Inc. has 4 FDA actions in our database, including 1 recall and 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 Aerin Medical, Inc. have FDA actions?
Aerin Medical, Inc. has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221907" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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