Duns Number:080909607
Device Description: The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handh The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that combines the ability to aspirate and break up soft tissue and fluids, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site, during minimally invasive surgical procedures.
Catalog Number
AEC12F/70
Brand Name
AURORA Evacuator +Coag
Version/Model Number
AEC12F/70
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
K201637
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
f7a3f812-da93-4477-bf79-8ee5f08bb3e8
Public Version Date
October 13, 2021
Public Version Number
4
DI Record Publish Date
January 12, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |