Duns Number:117077970
Device Description: The Controller of the EvoEndo Endoscopy System translates the images or video captured by The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable
Catalog Number
1002
Brand Name
EvoEndo Controller
Version/Model Number
EE-C
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K213606
Product Code
FET
Product Code Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Public Device Record Key
e7f95954-b645-4f6c-9ac4-aa371d926af8
Public Version Date
March 07, 2022
Public Version Number
1
DI Record Publish Date
February 25, 2022
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. | 3 |