# K113021: Trufreeze System, Trufreeze Spray Kit

- Pathway: 510(k) (Traditional)
- Applicant: CSA Medical, Inc.
- Decided: Feb 7, 2012 after 119 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: 4 generations back to K840536 (1984). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040809: Crymed Cryo-Ablator, Crymed Technologies, Inc. (2004) Summary page 1.
- K060555: Spraygenix Cryo Ablation System, Crymed Technologies, Inc. (2006) Summary page 1.
- K090138: Mobilecare Monitor, Model 2100, Aframe Digital, Inc. (2009) Summary page 1.
- K093557: Smartwand-DTX, Clearcount Medical Solutions (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K070265: Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit, Model 01-090000, Diagnostic Hybrids, Inc. (2007). Our reading of the summary gave K070265, FDA’s number for Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus… (Diagnostic Hybrids, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CryoSpray Ablation System”. Kept off the family tree. Summary page 1.

## Indications for use
The truFreeze® System is intended for use as a cryosuirgical tool for the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery.

Source page: https://510kreport.com/device/K113021
Methodology: https://510kreport.com/methodology