# K200300: VivAer Stylus

- Pathway: 510(k) (Special)
- Applicant: Aerin Medical, Inc.
- Decided: Apr 13, 2020 after 67 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000778 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172529: Vivaer ARC Stylus, Aerin Medical, Inc. (2017) Summary page 4.

## Recalls of this device
- Nov 12, 2024 · Class II · Z-0808-2025: Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.

## Indications for use
The VivAer® 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, including cartilage in the internal nasal valve area.

Source page: https://510kreport.com/device/K200300
Methodology: https://510kreport.com/methodology