Identity
- Trade Name
- RhinAer+ Stylus FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- The RhinAer+ Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The RhinAer+ Stylus consists of a handle, shaft, and treatment tip. An array of bipolar electrodes are positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator via a flexible cable. FDA UDI
- Model / Reference
- FG2258 FDA UDI
- Description
- The RhinAer+ Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The RhinAer+ Stylus consists of a handle, shaft, and treatment tip. An array of bipolar electrodes are positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator via a flexible cable. FDA UDI
Identifiers
- Catalog Number
- CAT2259 FDA UDI
- Primary DI / UDI-DI
- 08886479300306 FDA UDI
- 510(k) Number
- K221907 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical system
RhinAer+ Stylus by Aerin Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K221907 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aerin Medical Inc.
Sources (1)
- FDA UDI 8128e599-641b-463d-a916-adfb05854c70 37 fields · synced Jun 8, 2026