# K150920: truFreeze System

- Pathway: 510(k) (Traditional)
- Applicant: CSA Medical, Inc.
- Decided: Jun 17, 2015 after 72 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: 10 generations back to K003811 (2001). 22 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143625: truFreeze System, CSA Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K152668: truFreeze System (2015), 10 descendants of its own
- K160273: truFreeze System (2016), 9 descendants of its own
- K161557: truFreeze System (2016), 8 descendants of its own
- K162695: truFreeze System (2016), 7 descendants of its own
- K163244: truFreeze System (2017), 5 descendants of its own

## Indications for use
The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures, The truFreeze® System is Indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant

Source page: https://510kreport.com/device/K150920
Methodology: https://510kreport.com/methodology