# K260255: AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)

- Pathway: 510(k) (Traditional)
- Applicant: Aventix Medical, Inc.
- Decided: Mar 27, 2026 after 58 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). 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)
- K221907: RhinAer® Stylus (FG1393), Aerin Medical, Inc. (2022) Summary page 6.
- K162810: InSeca ARC Stylus, Aerin Console, Aerin Medical, Inc. (2017) Summary page 6.

## Indications for use
The AVENTIX™ PFX System is an electrosurgical system intended to generate Pulsed Field Energy (PFE) for use with the NOVOCLEAR™ Device. The AVENTIX™ PFX System is indicated for use in small clinics, offices and/or hospital environments. The NOVOCLEAR™ Device is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including the posterior nasal nerve distribution in patients with chronic rhinitis.

Source page: https://510kreport.com/device/K260255
Methodology: https://510kreport.com/methodology