# K022314: Sanarus Visica Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Sanarus Medical, Inc.
- Decided: Oct 15, 2002 after 90 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: 3 generations back to K003811 (2001). 7 ancestors in all.
29 later devices descend from it; 2 cite 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)
- K021211: Modification to Sanarus Visica Treatment System, Sanarus Medical, Inc. (2002) Summary page 2.
- K012023: Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable, Senorx, Inc. (2001) Summary page 2.

## Most influential descendants
- K052861: Modification to:Sanarus Visica Treatment System , Models VS2000 (2005), 28 descendants of its own
- K061510: Sanarus Visica Treatment System (2006), 27 descendants of its own
- 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

## Recalls of this device
- Jun 16, 2003 · Not classified · Z-1008-03: Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.

## Indications for use
The Sanarus Visica Treatment System is intended 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/K022314
Methodology: https://510kreport.com/methodology