Duns Number:690514869
Device Description: The RF Ablation System V-1000 is a microprocessor-based generator. This generator provides The RF Ablation System V-1000 is a microprocessor-based generator. This generator provides up to 140 W of RF energy to be used for coagulation & ablation of vessel, tissue and bone.
Catalog Number
-
Brand Name
RF ABLATION SYSTEM V-1000
Version/Model Number
V-1000
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
K180999
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
3d4f8560-35de-4b1c-8c58-b912c885e9aa
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
July 31, 2019
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. | 13 |