FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RhinAer+ Stylus
K Number: K260522
·
Decision May 18, 2026
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
10
Review Days
90
Basic Information
- Device Name
- RhinAer+ Stylus
- K Number
- K260522
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aerin Medical, Inc.
- Date Received
- February 17, 2026
- Decision Date
- May 18, 2026
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Aerin Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242630 | Aerin Console | Dec 10, 2024 | Substantially Equivalent |
| K240253 | Reach Needle | Mar 21, 2024 | Substantially Equivalent |
| K221907 | RhinAer® Stylus (FG1393) | Jul 29, 2022 | Substantially Equivalent |
| K200300 | VivAer Stylus | Apr 13, 2020 | Substantially Equivalent |
| K192471 | RHIN1 Stylus | Dec 20, 2019 | Substantially Equivalent |
| K172529 | Vivaer ARC Stylus | Dec 5, 2017 | Substantially Equivalent |
| K162810 | InSeca ARC Stylus, Aerin Console | Jan 11, 2017 | Substantially Equivalent |
| K161994 | Aerin Medical Stylus | Sep 22, 2016 | Substantially Equivalent |
| K150637 | Aerin Medical Wand Model FG011 | Nov 19, 2015 | Substantially Equivalent |