Duns Number:831350785
Device Description: The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that c The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that controls one single use disposable probe. The system utilizes a cryogen, liquid nitrogen, as a cooling agent and a resistance heater for thawing. The Visica 2 Console is a self contained, mobile unit featuring an easy to use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allow users to select treatment modes, times, and cycles.
Catalog Number
VS3000
Brand Name
Visica 2
Version/Model Number
VS3000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062896
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
337272b5-a125-4709-929c-8d420781ee29
Public Version Date
April 08, 2022
Public Version Number
5
DI Record Publish Date
September 06, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |