# K050090: Gel Mark V

- Pathway: 510(k) (Special)
- Applicant: Senorx, Inc.
- Decided: Feb 7, 2005 after 24 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K123911: Senomark Ultra Breast Tissue Marker (2013), 0 descendants of its own

## Indications for use
The Gel Mark V is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.

Source page: https://510kreport.com/device/K050090
Methodology: https://510kreport.com/methodology