# K162810: InSeca ARC Stylus, Aerin Console

- Pathway: 510(k) (Traditional)
- Applicant: Aerin Medical, Inc.
- Decided: Jan 11, 2017 after 97 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: 3 generations back to K000778 (2000). 3 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161994: Aerin Medical Stylus, Aerin Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K192471: RHIN1 Stylus (2019), 4 descendants of its own
- K212666: Neuromark System (2021), 3 descendants of its own
- K222032: NEUROMARK System (2022), 2 descendants of its own
- K250048: NEUROMARK System (NMK00301) (2025), 1 descendant of its own
- K172529: Vivaer ARC Stylus (2017), 1 descendant of its own

## Indications for use
The InSeca ARC Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue. The Aerin Console is an electrosurgical system intended to generate radiofrequency electrical current for the use of an ARC Stylus (e.g., InSeca ARC Stylus). The Aerin Console is indicated for use in small clinic, office or hospital environments.

Source page: https://510kreport.com/device/K162810
Methodology: https://510kreport.com/methodology