# K150637: Aerin Medical Wand Model FG011

- Pathway: 510(k) (Traditional)
- Applicant: Aerin Medical, Inc.
- Decided: Nov 19, 2015 after 253 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: 1 generation back to K000778 (2000). 1 ancestor in all.
11 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)
- K000778: Entec Reflex Wand 55, Model E4055-01, E4045-01, Arthrocare Corp. (2000) Summary page 4.

## Most influential descendants
- K161994: Aerin Medical Stylus (2016), 10 descendants of its own
- 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

## Indications for use
The Aerin Medical Wand 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 subnmcosal tissue.

Source page: https://510kreport.com/device/K150637
Methodology: https://510kreport.com/methodology