Duns Number:312623008
Device Description: The product is a variant of a navigated suction instrument for image guided surgical proce The product is a variant of a navigated suction instrument for image guided surgical procedures .The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument is indicated for any medical condition in which the use ofstereotactic surgery may be appropriate and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Catalog Number
-
Brand Name
PointerTube Kennedy
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
K163416,K163416
Product Code
PGW
Product Code Name
Ear, Nose, And Throat Stereotaxic Instrument
Public Device Record Key
0962a9c7-63e5-48d7-8637-0e5d8a2f0e91
Public Version Date
October 25, 2022
Public Version Number
6
DI Record Publish Date
November 21, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |