# K061510: Sanarus Visica Treatment System

- Pathway: 510(k) (Special)
- Applicant: Sanarus Medical, Inc.
- Decided: Jul 18, 2006 after 47 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: 5 generations back to K003811 (2001). 9 ancestors in all.
27 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022314: Sanarus Visica Treatment System, Sanarus Medical, Inc. (2002) Summary page 2.
- K052861: Modification to:Sanarus Visica Treatment System , Models VS2000, Sanarus Medical, Inc. (2005) Summary page 2.

## Most influential descendants
- K062896: V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600 (2007), 26 descendants of its own
- K102360: Icesence 3 (2010), 25 descendants of its own
- K133258: Trufreeze System (2014), 20 descendants of its own
- K143625: truFreeze System (2015), 19 descendants of its own
- K150920: truFreeze System (2015), 11 descendants of its own

## Indications for use
The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications: General Surgery Ablation of breast fibroadenoma Localization of breast lesions Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia Oncology Ablation of cancerous or malignant tissue Ablation of benign tumors Palliative intervention

Source page: https://510kreport.com/device/K061510
Methodology: https://510kreport.com/methodology