# K161994: Aerin Medical Stylus

- Pathway: 510(k) (Special)
- Applicant: Aerin Medical, Inc.
- Decided: Sep 22, 2016 after 65 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: 2 generations back to K000778 (2000). 2 ancestors in all.
10 later devices descend from it; 1 cites 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)
- K150637: Aerin Medical Wand Model FG011, Aerin Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K162810: InSeca ARC Stylus, Aerin Console (2017), 9 descendants of its own
- 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

## Indications for use
The Aerin Medical 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.

Source page: https://510kreport.com/device/K161994
Methodology: https://510kreport.com/methodology