# K060808: Brainpro, Brainpro Access

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Jul 25, 2006 after 123 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924348 (1992). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032054: Radionics Nashold Biopsy Needle - Single Use, Radionics, A Division of Tyco Healthcare Group LP (2003) Summary page 1.
- K924348: AD-Tech's Brain Biopsy Needle for Stereotaxic, Ad-Tech Medical Instrument Corp (1992) Summary page 1.
- K801760: Field-Lee Brain Biopsy Needle, American V. Mueller (1980) Summary page 1.

## Most influential descendants
- K220897: Disposable Brain Biopsy Needle 2.0 (2022), 1 descendant of its own
- K230201: Disposable Pre-calibrated Brain Biopsy Needle 2.0 (2023), 0 descendants of its own
- K112094: Brain Biopsy Needle (2012), 0 descendants of its own

## Indications for use
The Pajunk BrainPro biopsy cannula for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The BrainPro is provided in a set. The Pajunk BrainPro Biopsy Needle is a dual cannula device made from stainless steel or titanium. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue. The Pajunk BrainPro Access is an optional single-use anchoring and guidance instrument for Pajunks BrainPro biopsy cannula with cutting titanium thread for drill holes. It is used in brain biopsy procedures. The BrainPro Access is provided sterile.

Source page: https://510kreport.com/device/K060808
Methodology: https://510kreport.com/methodology