# K990278: Daum Neurocut Neurobiopsyneedle

- Pathway: 510(k) (Traditional)
- Applicant: Daum Corp.
- Decided: Mar 30, 1999 after 61 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K032054: Radionics Nashold Biopsy Needle - Single Use (2003), 4 descendants of its own
- 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 Daum NeuroCut NeuroBiopsyNeedle is designed for b:opsy of the soft tissue in the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K990278
Methodology: https://510kreport.com/methodology