Duns Number:344007369
Device Description: The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endosc The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection • for thick tissue (needle length of 3.0 mm)
Catalog Number
200.53.04
Brand Name
ESD AqaNife
Version/Model Number
3.0 mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 26, 2018
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"
Yes
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
K141790
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
8ddf53ea-3959-4478-bad2-7f8cf9e91a3a
Public Version Date
October 31, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 61 |