# K162608: ClariFix Device

- Pathway: 510(k) (Traditional)
- Applicant: Arrinex, Inc.
- Decided: Feb 14, 2017 after 148 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: 2 generations back to K024009 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160669: ClariFix Device, Arrinex, Inc. (2016) Summary page 4.

## Most influential descendants
- K190356: ClariFix (2019), 0 descendants of its own

## 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/K162608
Methodology: https://510kreport.com/methodology