# K974631: Daum Neurobiopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Daum Corp.
- Decided: Mar 9, 1998 after 87 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Daum NeuroBiopsy Needle is designed for biopsy of the soft tissues in the brain. The Daum NeuroBiopsy Needle is also a low-artifact-instrument designed to be used in the MRI for the above purpose. Federal (U.S.A) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K974631
Methodology: https://510kreport.com/methodology