# K021098: Daum-Lectric Mri Drilling Machine

- Pathway: 510(k) (Traditional)
- Applicant: Mri Devices Daum GmbH
- Decided: Dec 3, 2002 after 243 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- 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 p-lectric Drilling Machine is a piezoelectrically.driven hand held drill intended 'to assist the surgeon to access'bony tissue. The Daum p-lectric Drilling Machine can drill into hard.'and soft bone tissue to creale a small hole or to obtain bony tissue samples, The Daum p-lectric Drilfing Machine &designed to be 'used inside or close to an MRI Unit up to 1.5 Tesla.

Source page: https://510kreport.com/device/K021098
Methodology: https://510kreport.com/methodology