# K190356: ClariFix

- Pathway: 510(k) (Special)
- Applicant: Arrinex, Inc.
- Decided: Feb 26, 2019 after 11 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- 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 K024009 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162608: ClariFix Device, Arrinex, Inc. (2017) Summary page 4.

## Indications for use
The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

Source page: https://510kreport.com/device/K190356
Methodology: https://510kreport.com/methodology