# K032054: Radionics Nashold Biopsy Needle - Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, A Division of Tyco Healthcare Group LP
- Decided: Sep 15, 2003 after 75 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: 1 generation back to K924348 (1992). 2 ancestors in all.
4 later devices descend 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)
- K990278: Daum Neurocut Neurobiopsyneedle, Daum Corp. (1999) Summary page 1.
- K924348: AD-Tech's Brain Biopsy Needle for Stereotaxic, Ad-Tech Medical Instrument Corp (1992) Summary page 1.
- (no number) Elekta Instrument’s Leksell Sedan Biopsy Needle: named in the summary without a submission number

## Most influential descendants
- K060808: Brainpro, Brainpro Access (2006), 3 descendants of its own
- 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 Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors.

Source page: https://510kreport.com/device/K032054
Methodology: https://510kreport.com/methodology