# K990782: Daum Neurogate Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Daum GmbH
- Decided: Apr 28, 1999 after 50 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 NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into a bore hole in the top of the skull. The insertion is done with the aid of an insertion tool. This trocar fimction is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (1 1G, 14G, 16G) allowing a combination with 2!l Daum neuro needles.

Source page: https://510kreport.com/device/K990782
Methodology: https://510kreport.com/methodology