← Back to catalogue

InSeca ARC Stylus, Aerin Console

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K162810

by Aerin Medical Inc.

Identifiers

510(k) Number
K162810 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 InSeca ARC Stylus and Aerin Console is an electrosurgical system designed for cutting and coagulation procedures. It generates radiofrequency electrical current to facilitate tissue manipulation in surgical settings, classified under electrosurgical accessories for general and plastic surgery applications.

This system is intended for use in small clinic, office, or hospital environments. The InSeca ARC Stylus and Aerin Console has received FDA 510(k) clearance under the Traditional pathway, with a classification under regulation 878.4400. The device is supplied as a reusable electrosurgical console paired with disposable or reusable stylus probes, adhering to regulatory standards for electrosurgical equipment.

Frequently asked questions

What types of surgical procedures is the InSeca ARC Stylus system primarily used for, and in what settings can it be deployed?

The InSeca ARC Stylus and Aerin Console is designed for cutting and coagulation procedures, making it suitable for general and plastic surgery applications. It is intended for use in small clinics, office-based surgical settings, or hospitals where precise tissue manipulation is required during electrosurgical operations.

How is the InSeca ARC Stylus system supplied, and are the stylus probes disposable or reusable?

The system is supplied as a reusable electrosurgical console paired with stylus probes that can be either disposable or reusable, depending on clinical preference and infection control protocols. The console itself is not disposable and is intended for repeated use in surgical environments.

What regulatory pathway was followed for FDA clearance of the InSeca ARC Stylus, and what does this mean for its intended use?

The InSeca ARC Stylus received FDA 510(k) clearance under the Traditional pathway, classified under product code GEI (Electrosurgical accessories). This means the device was determined to be substantially equivalent to a legally marketed predicate device, confirming its compliance with safety and performance standards for electrosurgical accessories in general and plastic surgery applications.

Are there specific storage requirements for the InSeca ARC Stylus console, and how should it be maintained?

While the provided data does not specify storage details, reusable electrosurgical consoles like the InSeca ARC Stylus generally require clean, dry, and protected storage to prevent damage or contamination. Maintenance should follow manufacturer guidelines, including regular cleaning, calibration, and inspection to ensure optimal performance and safety in surgical settings.

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: InSeca ARC Stylus, Aerin Console (K162810) — FDA 510(k) | Innolitics, InSeca ARC Stylus, Aerin Console 510(k) K162810 - FDA.report, InSeca ARC Stylus, Aerin Console - BEUDAMED

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) K162810 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026