# K020605: Sanarus Visica Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Sanarus Medical, Inc.
- Decided: Mar 8, 2002 after 11 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: 1 generation back to K003811 (2001). 1 ancestor in all.
31 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003811: Cryocare Surgical System, Endocare, Inc. (2001)

## Most influential descendants
- K021211: Modification to Sanarus Visica Treatment System (2002), 30 descendants of its own
- K022314: Sanarus Visica Treatment System (2002), 29 descendants of its own
- 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

## Indications for use
The 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 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/K020605
Methodology: https://510kreport.com/methodology