# K991366: Daum Mri/Conventional Biopsy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Daum GmbH
- Decided: Jun 25, 1999 after 66 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 Dawm MRIConventional Biopsy Set consists of two parts, the Daum BiopsyGun and the Daum CoaxNeedle. The BiopsyGun is used for automatic biopsy of soft tissues, and the CoaxNeedle is intended for use in open and percutaneous surgical procedures of the brain. The patented surface treatment of the needle optimizes its use in the MRI setiing, producing a low-artifact visualization of the needle,

Source page: https://510kreport.com/device/K991366
Methodology: https://510kreport.com/methodology