Duns Number:312623008
Device Description: The products BiopsyPointer 190 referred to as BiopsyPointer is a product variant forthe na The products BiopsyPointer 190 referred to as BiopsyPointer is a product variant forthe navigation of neurosurgical brain biopsy cannulas.The instruments are accessories to the Fiagon Navigation system.The instruments in connection with the Navigation system are 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 cranialsurgery can be identified relative to a CT or MR based model of the anatomy.
Catalog Number
-
Brand Name
BiopsyPointer 190
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
K151156,K163209,K151156,K163209
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
53361710-4562-4aaa-94d0-ecda781f6043
Public Version Date
October 25, 2022
Public Version Number
6
DI Record Publish Date
August 10, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |