Manufacturer
Aerin Medical, Inc.RhinAer+ Stylus
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K260522
- Device name
- RhinAer+ Stylus
- Company
- Aerin Medical, Inc.
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2026-02-17
- Decision date
- 2026-05-18
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The RhinAer+ Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.
Intended Use
The RhinAer+ Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.
Device Description
modified to include clinical data as observational information without changing the intended use. A risk-based assessment did not identify new risks or significantly modify existing risks. Therefore, the subject device is substantially equivalent to the
Summary parsed at:2026-06-19 23:54:31 UTC
Predicate devices
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Not ingested
K260522 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K260522 as a predicate