← Back to catalogue

RhinAer Stylus FG1393

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221907

by Aerin Medical Inc.

Identifiers

510(k) Number
K221907 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 RhinAer Stylus FG1393 is a disposable handheld device designed for delivering bipolar radiofrequency energy to tissue. Classified under the product code GEI (General, Plastic Surgery), it is intended for use in procedures requiring controlled tissue modification. Its construction includes a handle, shaft, and treatment tip, enabling precise application of energy during surgical interventions.

This device is supplied as a single-use, non-sterile item and requires sterilization prior to use. It is intended for use in MRI-safe environments, as specified in its regulatory submissions. The RhinAer Stylus FG1393 holds FDA 510(k) clearance (K221907) and is authorized under the Medical Device Regulation (MDR). Storage and handling must comply with manufacturer guidelines to ensure proper functionality and safety.

Frequently asked questions

Is the RhinAer Stylus FG1393 intended for reuse, or is it designed as a single-use device that requires sterilization before each procedure?

The RhinAer Stylus FG1393 is explicitly supplied as a single-use, non-sterile device. It must be sterilized prior to use, as noted in the manufacturer’s instructions. This design ensures safety and compliance with procedural protocols, particularly in controlled surgical environments.

What types of surgical procedures is the RhinAer Stylus FG1393 intended to support, and how does its design enable precision in treatment?

The device is classified under product code GEI (General, Plastic Surgery) and is designed for procedures requiring controlled tissue modification. Its construction—featuring a handle, shaft, and treatment tip—allows clinicians to deliver bipolar radiofrequency energy with precision, making it suitable for applications where targeted tissue effects are critical.

Can this device be used in an MRI environment, and what considerations should be taken into account when storing or handling it?

Yes, the RhinAer Stylus FG1393 is MRI-safe, as specified in its regulatory submissions. However, storage and handling must strictly follow the manufacturer’s guidelines to maintain functionality and safety. Improper storage could compromise its performance or sterility before use.

What regulatory pathways has the RhinAer Stylus FG1393 followed, and how does this affect its availability or use in clinical settings?

The device holds FDA 510(k) clearance (K221907) and is authorized under the Medical Device Regulation (MDR). These pathways confirm its compliance with U.S. and EU regulatory standards, ensuring it meets safety and performance requirements for use in clinical settings. Availability depends on local regulatory approvals and distribution agreements.

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: PDF Instructions For Use - RhinAer® Stylus Model: FG1393 ... - Aerin Medical, RhinAer® Stylus FG1393 The RhinAer® Stylus is a… - FDA.report, Aerin Medical | Rhinitis & Nasal Airway Obstruction Treatment, RhinAer® Stylus (FG1393) (K221907) - FDA 510 (k)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aerin Medical Inc.
FDA Applicant
Aerin Medical, Inc.

Sources (2)

  • FDA 510(k) K221907 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026