Duns Number:694699723
Device Description: The VIVA combo RF System consists of RF generator, active electrode, grounding pad andperi The VIVA combo RF System consists of RF generator, active electrode, grounding pad andperistaltic pump for electrode cooling. This device is designed to produce local tissue heating atthe tip of the electrodes causing the coagulation and ablation of tissue.The VIVA combo RF System is capable of delivering up to 200 W of RF power and the availablepower is limited through software control. This generator monitors the power, resistance,current and temperature.
Catalog Number
VCS10
Brand Name
VIVA combo RF Generator
Version/Model Number
VCS10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 04, 2019
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
K163450
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
5c2afa92-5153-4476-a5b9-cc594c750f17
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
May 19, 2017
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. | 8 |