# K230201: Disposable Pre-calibrated Brain Biopsy Needle 2.0

- Pathway: 510(k) (Special)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Feb 22, 2023 after 28 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: 4 generations back to K924348 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220897: Disposable Brain Biopsy Needle 2.0, PAJUNK GmbH Medizintechnologie (2022) Summary page 5.

## Indications for use
The Disposable Pre-calibrated Biopsy Needle 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 Pre-calibrated Biopsy Needle is provided in a set. The Disposable Pre-calibrated Biopsy Needle 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. The Disposable Pre-calibrated Biopsy Needle is labelled as MRI conditional.

Source page: https://510kreport.com/device/K230201
Methodology: https://510kreport.com/methodology