# K172041: truFreeze System

- Pathway: 510(k) (Special)
- Applicant: CSA Medical, Inc.
- Decided: Jul 27, 2017 after 21 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: 16 generations back to K003811 (2001). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163244: truFreeze System, CSA Medical, Inc. (2017) Summary page 4.

## Indications for use
The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (eg. Barrett’s Esophagus with high grade dysplasia) and malignant lesions.

Source page: https://510kreport.com/device/K172041
Methodology: https://510kreport.com/methodology