# K220897: Disposable Brain Biopsy Needle 2.0

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Aug 17, 2022 after 142 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: 3 generations back to K924348 (1992). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060808: Brainpro, Brainpro Access, PAJUNK GmbH Medizintechnologie (2006) Summary page 5.

## Most influential descendants
- K230201: Disposable Pre-calibrated Brain Biopsy Needle 2.0 (2023), 0 descendants of its own

## Indications for use
The Disposable Brain Biopsy Needle 2.0 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 Disposable Brain Biopsy Needle 2.0 is provided in a set. The Disposable Brain Biopsy Needle 2.0 is a dual cannula device made from stainless steel. 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.

Source page: https://510kreport.com/device/K220897
Methodology: https://510kreport.com/methodology