# K242630: Aerin Console

- Pathway: 510(k) (Traditional)
- Applicant: Aerin Medical, Inc.
- Decided: Dec 10, 2024 after 98 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000778 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162810: InSeca ARC Stylus, Aerin Console, Aerin Medical, Inc. (2017) Summary page 5.

## Indications for use
The Aerin Console is an electrosurgical system intended to generate radiofrequency (RF) electrical current for the use of an Aerin Medical Stylus. The Aerin Console is indicated for use in small clinic, office or hospital environments.

Source page: https://510kreport.com/device/K242630
Methodology: https://510kreport.com/methodology