Duns Number:051512253
Device Description: The foot switch is an accessory for use with the Aerin Console which is an AC (alternating The foot switch is an accessory for use with the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.
Catalog Number
CAT307
Brand Name
Foot Switch
Version/Model Number
CAT307
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
K162810
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
86abce9c-ce79-45e3-bce6-c1a5ffc4435f
Public Version Date
February 18, 2019
Public Version Number
6
DI Record Publish Date
December 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. | 10 |