Duns Number:083171244
Device Description: The AURORA Surgiscope System consists of two components: sterile, single use, neurologica The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB). The AURORA Surgiscope includes the following parts: Sheath, Camera, LEDs (Light Emitting Diodes), Sheath Cable, and Obturator.
Catalog Number
ASX15/60
Brand Name
Aurora Surgiscope System
Version/Model Number
ASX15/60
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
K201840
Product Code
GWG
Product Code Name
Endoscope, Neurological
Public Device Record Key
dcdaa06e-8cc3-47a3-904d-5ad952428b11
Public Version Date
June 02, 2022
Public Version Number
3
DI Record Publish Date
May 18, 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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |