# K133258: Trufreeze System

- Pathway: 510(k) (Traditional)
- Applicant: CSA Medical, Inc.
- Decided: Jun 19, 2014 after 239 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K003811 (2001). 20 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102360: Icesence 3, IceCure Medical, Ltd. (2010) Summary page 1.

## Most influential descendants
- K143625: truFreeze System (2015), 19 descendants of its own
- K150920: truFreeze System (2015), 11 descendants of its own
- 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

## Recalls of this device
- Nov 10, 2014 · Class II · Z-0941-2015: An increase in complaint trending for a loss of audible sound associated with the timer has been observed.

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

Source page: https://510kreport.com/device/K133258
Methodology: https://510kreport.com/methodology