# K112094: Brain Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corp
- Decided: Apr 24, 2012 after 277 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924348: AD-Tech's Brain Biopsy Needle for Stereotaxic, Ad-Tech Medical Instrument Corp (1992) Summary page 1.
- K990278: Daum Neurocut Neurobiopsyneedle, Daum Corp. (1999) Summary page 1.
- K060808: Brainpro, Brainpro Access, PAJUNK GmbH Medizintechnologie (2006) Summary page 1.

## Indications for use
The Brain Biopsy Needles are used during guided procedures and by methods deemed safe by the physician/surgeon to remove a targeted tissue for biopsy.

Source page: https://510kreport.com/device/K112094
Methodology: https://510kreport.com/methodology