Duns Number:078684808
Device Description: The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree when connected to a standard electrosurgical generator. The EMPOWER RF Catheter is inserted through the bronchoscope/extended working channel of 2.0 mm ID or greater to reach the target site.
Catalog Number
10010
Brand Name
Empower RF Catheter
Version/Model Number
10010
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
Yes
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
K183240
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
16a1eb48-956f-4a3c-86fe-d0d86e35cc0b
Public Version Date
November 11, 2019
Public Version Number
1
DI Record Publish Date
November 01, 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. | 14 |