# K182082: Tumark for Eviva, Tumark for Brevera

- Pathway: 510(k) (Traditional)
- Applicant: Somatex Medical Technologies GmbH
- Decided: Oct 31, 2018 after 90 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K970817 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560, Somatex Medical Technologies GmbH (2010) Summary page 5.

## Indications for use
Tumark for Eviva and Tumark for Brevera are intended to attach a marker to soft tissue at the surgical site during a percutaneous procedure. The devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following a percutaneous procedure. They are not indicated to be used with magnetic resonance imaging (MRI) techniques.

Source page: https://510kreport.com/device/K182082
Methodology: https://510kreport.com/methodology