# K162695: truFreeze System

- Pathway: 510(k) (Special)
- Applicant: CSA Medical, Inc.
- Decided: Oct 25, 2016 after 28 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: 14 generations back to K003811 (2001). 26 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K161557: truFreeze System, CSA Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K163244: truFreeze System (2017), 5 descendants of its own
- K171626: truFreeze System (2017), 3 descendants of its own
- K222272: truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 (2022), 1 descendant of its own
- K223369: truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 (2022), 0 descendants of its own
- K201183: Vortex Radial Spray Catheter (2020), 0 descendants of its own

## Indications for use
The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of - 1960C 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 lesions.

Source page: https://510kreport.com/device/K162695
Methodology: https://510kreport.com/methodology