Fiagon GmbH

Address:Neuendorfstr. 23b,Hennigsdorf Brandenburg,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Neurological Stereotaxic Instrument (HAW) (3)

Premarket Exempt

No Yes

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BiopsyPointer 190 - EFIAN012050CUS1 Catalog Number :

Device Description : The products BiopsyPointer 190 referred to as BiopsyPointer is a product variant 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.

Device Class :

Duns Number: 312623008

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

BiopsyPointer 250 - EFIAN012051CUS1 Catalog Number :

Device Description : The product BiopsyPointer 250 referred to as BiopsyPointer is a product variant The product BiopsyPointer 250 referred to as BiopsyPointer is a product variant forthe navigation of neurosurgical brain biopsy cannulas.The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic 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 orMR based model of the anatomy.

Device Class :

Duns Number: 312623008

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ShuntPointer - EFIAN012060CUS1 Catalog Number :

Device Description : The product ShuntPointer is a product variant for the navigation of neurosurgica The product ShuntPointer is a product variant for the navigation of neurosurgical shunt placement.The instruments are accessories to the Fiagon Navigation system.The Navigation system is indicated for any medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identifiedrelative to a CT or MR based model of the anatomy.

Device Class :

Duns Number: 312623008

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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