Identifiers
- 510(k) Number
- K192471 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rhin1 Stylus is a device used to treat patients experiencing chronic rhinitis. It connects to the Aerin Console via a flexible cable and is used to deliver low power RF energy to the target tissue of the nasal airway. The device is inserted into a patient's nostril to position the treatment tip.
The Rhin1 Stylus is supplied with a shaft that is inserted into the nostril during a treatment procedure. It has FDA 510K clearance, with the clearance number K192471. The device is used in a clinical setting to treat nasal airway obstruction and chronic rhinitis.
Frequently asked questions
What is the Rhin1 Stylus used for?
The Rhin1 Stylus is used to treat patients experiencing chronic rhinitis and nasal airway obstruction by delivering low power RF energy to the target tissue.
How is the Rhin1 Stylus supplied?
The Rhin1 Stylus is supplied with a shaft that is inserted into the nostril during a treatment procedure, and is used in conjunction with the Aerin Console.
Is the Rhin1 Stylus sterile?
The device data does not explicitly state the sterility of the Rhin1 Stylus, but it is intended for use in a clinical setting.
Is the Rhin1 Stylus reusable?
The device data does not specify whether the Rhin1 Stylus is single-use or reusable, but it is designed for use in a clinical setting to treat multiple patients.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RHIN1 Stylus by Aerin Medical Inc. | FDA 510 (k) Summary, Aerin Medical | Rhinitis & Nasal Airway Obstruction Treatment, K192471 - RHIN1 Stylus | FDA 510 (k) | Aerin Medical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192471 | Class II | Active |
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Manufacturer
- Manufacturer
- Aerin Medical Inc.
- FDA Applicant
- Aerin Medical, Inc.
Sources (1)
- FDA 510(k) K192471 24 fields · synced Sep 24, 2026