RhinAer® Stylus (FG1393)
Electrosurgical, Cutting & Coagulation & Accessories
Aerin Medical Inc.
The following data is part of a premarket notification filed by Aerin Medical Inc. with the FDA for Rhinaer® Stylus (fg1393).
Pre-market Notification Details
| Device ID | K221907 |
| 510k Number | K221907 |
| Device Name: | RhinAer® Stylus (FG1393) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Aerin Medical Inc. 2565 Leghorn St. Mountain View, CA 91043 |
| Contact | Shannon Scott |
| Correspondent | Shannon Scott Aerin Medical Inc. 2565 Leghorn St. Mountain View, CA 91043 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-30 |
| Decision Date | 2022-07-29 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08886479300238 | K221907 | 000 |
| 08886479300306 | K221907 | 000 |
Trademark Results [RhinAer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RHINAER 90703279 not registered Live/Pending |
Aerin Medical Inc. 2021-05-11 |
 RHINAER 88495968 not registered Live/Pending |
Aerin Medical Inc. 2019-07-01 |
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